Trial Outcomes & Findings for Characteristics and Treatment Patterns of Patients With Chronic Obstructive Pulmonary Disease (COPD), Initiating Tio+Olo or Other Maintenance Therapies in the US and the UK: A Retrospective Claims Database Study (NCT NCT04926233)

NCT ID: NCT04926233

Last Updated: 2021-11-15

Results Overview

Age of the chronic obstructive pulmonary disease (COPD) patients at the time of COPD diagnosis from the United States (US) IBM MarketScan was reported by groups stratified according to their COPD diagnosis times (Before versus after the approval of Tiotropium + Olodaterol in 2015).

Recruitment status

COMPLETED

Target enrollment

1371146 participants

Primary outcome timeframe

At index date of cohort entry (baseline; time of COPD diagnosis).

Results posted on

2021-11-15

Participant Flow

This retrospective cohort study used previously collected administrative healthcare data (United States data from IBM MarketScan and United Kingdom data from CPRD GOLD, a primary care database) to describe the patients characteristics and treatment patterns in patients with chronic obstructive pulmonary disease (COPD), initiating tiotropium + olodaterol or other maintenance therapies.

Patients with chronic obstructive pulmonary disease (COPD) who met all inclusion criteria and none of the exclusion criteria initiating tiotropium + olodaterol or other maintenance therapies from either IBM MarketScan (United States) or CPRD GOLD (United Kingdom) databases were included.

Participant milestones

Participant milestones
Measure
US IBM Marketscan - Overall
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).
UK CPRD GOLD - Overall
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
Overall Study
STARTED
1280486
90660
Overall Study
COMPLETED
1280486
90660
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
US IBM Marketscan - Overall
n=1280486 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).
UK CPRD GOLD - Overall
n=90660 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
Total
n=1371146 Participants
Total of all reporting groups
Age, Continuous
65.3 Years
STANDARD_DEVIATION 13.2 • n=1280486 Participants
65.9 Years
STANDARD_DEVIATION 13.5 • n=90660 Participants
65.3 Years
STANDARD_DEVIATION 13.2 • n=1371146 Participants
Sex: Female, Male
Female
649296 Participants
n=1280486 Participants
46923 Participants
n=90660 Participants
696219 Participants
n=1371146 Participants
Sex: Female, Male
Male
631190 Participants
n=1280486 Participants
43737 Participants
n=90660 Participants
674927 Participants
n=1371146 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: At index date of cohort entry (baseline; time of COPD diagnosis).

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018).

Age of the chronic obstructive pulmonary disease (COPD) patients at the time of COPD diagnosis from the United States (US) IBM MarketScan was reported by groups stratified according to their COPD diagnosis times (Before versus after the approval of Tiotropium + Olodaterol in 2015).

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=1021963 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=258523 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - US
65.6 Years
Standard Deviation 13.3
64.4 Years
Standard Deviation 12.8

PRIMARY outcome

Timeframe: At index date of cohort entry (baseline; time of COPD diagnosis).

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).

Age of the chronic obstructive pulmonary disease (COPD) patients at the time of COPD diagnosis from the the United Kingdom (UK) CPRD GOLD database was reported by groups stratified according to their COPD diagnosis times (Before versus after the approval of Tiotropium + Olodaterol in 2015).

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=79412 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=11248 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - UK
65.82 Years
Standard Deviation 13.81
66.17 Years
Standard Deviation 11.17

PRIMARY outcome

Timeframe: At index date of cohort entry (baseline; time of COPD diagnosis).

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan (contained data collected from January 1, 2008 to March 31, 2018) and the United Kingdom (UK) CPRD GOLD databases (contained data collected from November 21, 1987 to June 30, 2018). Results were reported by overall and by stratified groups according to Tiotropium + Olodaterol approval date for US and UK datasets, respectively.

The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=1280486 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=1021963 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=258523 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=90660 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=79412 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=11248 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Charlson Comorbidity Index (CCI) at the Time of COPD Diagnosis
1.6 Score on a scale
Standard Deviation 1.9
1.5 Score on a scale
Standard Deviation 1.9
1.9 Score on a scale
Standard Deviation 2.1
1.89 Score on a scale
Standard Deviation 1.38
1.83 Score on a scale
Standard Deviation 1.32
2.31 Score on a scale
Standard Deviation 1.66

PRIMARY outcome

Timeframe: At index date of the first maintenance treatment

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium + Olodaterol; 21 May 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.

Age of chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United States (US) IBM MarketScan database was reported.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=53473 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=6737 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=351 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=26378 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=6745 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=2237 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=10892 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=133 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Age of Patients Receiving First Maintenance Treatment - US
63.0 Years
Interval 57.0 to 73.0
62.0 Years
Interval 56.0 to 73.0
67.0 Years
Interval 59.0 to 79.0
62.0 Years
Interval 56.0 to 72.0
62.0 Years
Interval 56.0 to 72.0
63.0 Years
Interval 58.0 to 74.0
64.0 Years
Interval 58.0 to 75.0
65.0 Years
Interval 58.0 to 76.0

PRIMARY outcome

Timeframe: At index date of the first maintenance treatment

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium + Olodaterol; 21 May 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.

The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=53473 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=6737 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=351 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=26378 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=6745 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=2237 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=10892 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=133 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Charlson Comorbidity Index (CCI) of Patients Receiving First Maintenance Treatment - US
2.0 Score on a scale
Interval 1.0 to 4.0
2.0 Score on a scale
Interval 1.0 to 4.0
2.0 Score on a scale
Interval 1.0 to 5.0
2.0 Score on a scale
Interval 1.0 to 4.0
2.0 Score on a scale
Interval 1.0 to 3.0
2.0 Score on a scale
Interval 1.0 to 4.0
2.0 Score on a scale
Interval 1.0 to 4.0
2.0 Score on a scale
Interval 1.0 to 4.0

PRIMARY outcome

Timeframe: At index date of the first maintenance treatment

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium + Olodaterol; 21 May 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.

Characteristics of patients receiving first maintenance treatment among chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United States (US) IBM MarketScan database were reported.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=53473 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=6737 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=351 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=26378 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=6745 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=2237 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=10892 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=133 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Characteristics of Patients Receiving First Maintenance Treatment - US
Upper respiratory tract infection
13803 Participants
2114 Participants
87 Participants
7151 Participants
1632 Participants
486 Participants
2299 Participants
34 Participants
Characteristics of Patients Receiving First Maintenance Treatment - US
Lower respiratory tract infection
8525 Participants
1160 Participants
46 Participants
4577 Participants
885 Participants
367 Participants
1474 Participants
16 Participants
Characteristics of Patients Receiving First Maintenance Treatment - US
Pneumonia
9946 Participants
1253 Participants
77 Participants
4762 Participants
1014 Participants
651 Participants
2160 Participants
29 Participants
Characteristics of Patients Receiving First Maintenance Treatment - US
Chronic bronchitis
5161 Participants
603 Participants
42 Participants
2642 Participants
502 Participants
294 Participants
1066 Participants
12 Participants
Characteristics of Patients Receiving First Maintenance Treatment - US
Lung fibrosis
1868 Participants
239 Participants
22 Participants
882 Participants
207 Participants
108 Participants
405 Participants
5 Participants
Characteristics of Patients Receiving First Maintenance Treatment - US
Concomitant medications - Oral corticosteroids
23272 Participants
3172 Participants
152 Participants
12240 Participants
2770 Participants
929 Participants
3959 Participants
50 Participants
Characteristics of Patients Receiving First Maintenance Treatment - US
Concomitant medications - Oral antibiotics
37829 Participants
5047 Participants
249 Participants
19168 Participants
4645 Participants
1508 Participants
7116 Participants
96 Participants
Characteristics of Patients Receiving First Maintenance Treatment - US
Concomitant medications - Oxygen therapy
4580 Participants
425 Participants
57 Participants
2094 Participants
625 Participants
305 Participants
1058 Participants
16 Participants

PRIMARY outcome

Timeframe: At index date of the first maintenance treatment

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium+Olodaterol; 1 July 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.

Age of patients receiving first maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=8786 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=753 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=382 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=1202 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=1407 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=352 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=4675 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=15 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Age of Patients Receiving First Maintenance Treatment - UK
68.0 Years
Interval 60.0 to 75.0
67.0 Years
Interval 59.0 to 75.0
67.0 Years
Interval 59.0 to 75.0
67.0 Years
Interval 59.0 to 75.0
68.0 Years
Interval 61.0 to 75.0
70.0 Years
Interval 62.0 to 77.0
68.0 Years
Interval 60.0 to 75.0
69.0 Years
Interval 64.0 to 73.0

PRIMARY outcome

Timeframe: At index date of the first maintenance treatment

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium+Olodaterol; 1 July 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.

Characteristics of patients receiving first maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=8786 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=753 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=382 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=1202 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=1407 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=352 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=4675 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=15 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Characteristics of Patients Receiving First Maintenance Treatment - UK
Upper respiratory tract infection
3802 Participants
454 Participants
166 Participants
545 Participants
541 Participants
143 Participants
1946 Participants
7 Participants
Characteristics of Patients Receiving First Maintenance Treatment - UK
Lower respiratory tract infection (not pneumonia)
4835 Participants
501 Participants
220 Participants
721 Participants
732 Participants
164 Participants
2486 Participants
11 Participants
Characteristics of Patients Receiving First Maintenance Treatment - UK
Concomitant medications - Oral corticosteroids
2367 Participants
207 Participants
87 Participants
453 Participants
353 Participants
121 Participants
1140 Participants
6 Participants
Characteristics of Patients Receiving First Maintenance Treatment - UK
Concomitant medications - Oral antibiotics
5133 Participants
480 Participants
204 Participants
796 Participants
797 Participants
224 Participants
2624 Participants
8 Participants

PRIMARY outcome

Timeframe: At index date of the second maintenance treatment

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.

Age of patients receiving second maintenance treatment from the United States (US) IBM MarketScan database was reported.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=7028 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=584 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=82 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=1813 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=1125 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=1834 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=1450 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=140 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Age of Patients Receiving Second Maintenance Treatment - US
64.0 Years
Interval 58.0 to 74.0
63.0 Years
Interval 57.0 to 74.0
70.0 Years
Interval 62.0 to 79.0
63.0 Years
Interval 58.0 to 73.0
63.0 Years
Interval 58.0 to 73.0
64.0 Years
Interval 58.0 to 73.0
64.0 Years
Interval 59.0 to 75.0
65.0 Years
Interval 60.0 to 78.5

PRIMARY outcome

Timeframe: At index date of the second maintenance treatment

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.

The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=7028 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=584 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=82 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=1813 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=1125 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=1834 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=1450 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=140 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Charlson Comorbidity Index (CCI) of Patients Receiving Second Maintenance Treatment - US
2.0 Score on a scale
Interval 1.0 to 4.0
2.0 Score on a scale
Interval 2.0 to 4.0
3.0 Score on a scale
Interval 1.0 to 4.0
2.0 Score on a scale
Interval 1.0 to 4.0
2.0 Score on a scale
Interval 1.0 to 4.0
2.0 Score on a scale
Interval 1.0 to 4.0
3.0 Score on a scale
Interval 2.0 to 4.0
2.0 Score on a scale
Interval 1.0 to 5.0

PRIMARY outcome

Timeframe: At index date of the second maintenance treatment

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.

Characteristics of patients receiving second maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United States (US) IBM MarketScan database were reported.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=7028 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=584 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=82 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=1813 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=1125 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=1834 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=1450 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=140 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Characteristics of Patients Receiving Second Maintenance Treatment - US
Lung fibrosis
388 Participants
37 Participants
11 Participants
101 Participants
43 Participants
105 Participants
79 Participants
12 Participants
Characteristics of Patients Receiving Second Maintenance Treatment - US
Male
3674 Participants
265 Participants
41 Participants
920 Participants
628 Participants
998 Participants
749 Participants
73 Participants
Characteristics of Patients Receiving Second Maintenance Treatment - US
Upper respiratory tract infection
1842 Participants
196 Participants
25 Participants
497 Participants
307 Participants
442 Participants
343 Participants
32 Participants
Characteristics of Patients Receiving Second Maintenance Treatment - US
Lower respiratory infections
1385 Participants
130 Participants
13 Participants
368 Participants
213 Participants
372 Participants
260 Participants
29 Participants
Characteristics of Patients Receiving Second Maintenance Treatment - US
Chronic bronchitis
1095 Participants
89 Participants
11 Participants
264 Participants
165 Participants
297 Participants
243 Participants
26 Participants
Characteristics of Patients Receiving Second Maintenance Treatment - US
Concomitant medications - Oral corticosteroids
4065 Participants
355 Participants
44 Participants
1019 Participants
595 Participants
1125 Participants
851 Participants
75 Participants
Characteristics of Patients Receiving Second Maintenance Treatment - US
Concomitant medications - Oral antibiotics
5399 Participants
481 Participants
64 Participants
1399 Participants
833 Participants
1388 Participants
1126 Participants
108 Participants

PRIMARY outcome

Timeframe: At index date of the second maintenance treatment

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018) initiated their second maintenance therapy at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.

Age of patients receiving second maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=2461 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=60 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=101 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=338 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=970 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=685 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=222 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=85 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Age of Patients Receiving Second Maintenance Treatment - UK
68.0 Years
Interval 61.0 to 75.0
68.0 Years
Interval 61.5 to 74.0
71.0 Years
Interval 63.0 to 76.0
69.0 Years
Interval 61.0 to 77.0
68.0 Years
Interval 61.0 to 74.0
68.0 Years
Interval 60.0 to 74.0
70.0 Years
Interval 62.0 to 77.0
68.0 Years
Interval 59.0 to 73.0

PRIMARY outcome

Timeframe: At index date of the second maintenance treatment

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018) initiated their second maintenance therapy at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.

Characteristics of patients receiving second maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=2461 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=60 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=101 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=338 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=970 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=685 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=222 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=85 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Characteristics of Patients Receiving Second Maintenance Treatment - UK
Male
1375 Participants
31 Participants
51 Participants
191 Participants
555 Participants
383 Participants
127 Participants
37 Participants
Characteristics of Patients Receiving Second Maintenance Treatment - UK
Concomitant medications - Oral corticosteroids
1066 Participants
25 Participants
36 Participants
152 Participants
356 Participants
385 Participants
71 Participants
41 Participants

SECONDARY outcome

Timeframe: At index date of the first maintenance treatment

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium + Olodaterol; 21 May 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.

Number of participants with zero exacerbations in the year prior to the start of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy the United States (US) IBM MarketScan database was reported.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=53473 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=6737 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=351 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=26378 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=6745 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=2237 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=10892 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=133 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Number of Participants With Zero Exacerbations in the Year Prior to the Start of First Maintenance Therapy - US
26242 Participants
3518 Participants
183 Participants
12483 Participants
3818 Participants
676 Participants
5515 Participants
49 Participants

SECONDARY outcome

Timeframe: At index date of the first maintenance treatment

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium+Olodaterol; 1 July 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.

Number of participants with zero exacerbations in the year prior to the start of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=8786 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=753 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=382 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=1202 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=1407 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=352 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=4675 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=15 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Number of Participants With Zero Exacerbations in the Year Prior to the Start of First Maintenance Therapy - UK
5942 Participants
498 Participants
275 Participants
712 Participants
960 Participants
207 Participants
3281 Participants
9 Participants

SECONDARY outcome

Timeframe: At index date of the second maintenance treatment

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.

Number of participants with zero exacerbations in the year prior to the start of second maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy the United States (US) IBM MarketScan database was reported.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=7028 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=584 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=82 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=1813 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=1125 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=1834 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=1450 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=140 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Number of Participants With Zero Exacerbations in the Year Prior to the Start of Second Maintenance Therapy - US
2361 Participants
226 Participants
29 Participants
684 Participants
426 Participants
505 Participants
451 Participants
40 Participants

SECONDARY outcome

Timeframe: At index date of the second maintenance treatment

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018) initiated their second maintenance therapy at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.

Number of participants with zero exacerbations in the year prior to the start of second maintenance therapy among chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=2461 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=60 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=101 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=338 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=970 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=685 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=222 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=85 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Number of Participants With Zero Exacerbations in the Year Prior to the Start of Second Maintenance Therapy - UK
1351 Participants
34 Participants
63 Participants
172 Participants
590 Participants
299 Participants
144 Participants
49 Participants

SECONDARY outcome

Timeframe: From index date until initiation of first maintenance, up to 3368 days before this study started.

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium + Olodaterol; 21 May 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.

Days between index and initiation of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy the United States (US) IBM MarketScan database was reported.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=53473 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=6737 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=351 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=26378 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=6745 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=2237 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=10892 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=133 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Days Between Index and Initiation of First Maintenance Therapy - US
158.0 Days
Interval 12.0 to 839.0
242.0 Days
Interval 17.0 to 972.0
233.0 Days
Interval 14.0 to 902.0
165.0 Days
Interval 12.0 to 833.0
116.0 Days
Interval 15.0 to 672.0
78.0 Days
Interval 7.0 to 770.0
136.0 Days
Interval 9.0 to 879.0
85.0 Days
Interval 6.0 to 957.0

SECONDARY outcome

Timeframe: From index date until initiation of first maintenance therapy, up to 9795 days before this study started.

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018) initiated their first maintenance therapy at the time of or after the launch date of Sp(t)iolto (referred to as Tiotropium+Olodaterol; 1 July 2015), and were free from asthma. Results were reported by overall and by stratified groups according to therapies.

Days between index and initiation of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=8786 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=753 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=382 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=1202 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=1407 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=352 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=4675 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=15 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Days Between Index and Initiation of First Maintenance Therapy - UK
28.5 Days
Interval 1.0 to 521.0
708.0 Days
Interval 43.0 to 3145.0
43.5 Days
Interval 1.0 to 555.0
32.0 Days
Interval 1.0 to 566.0
19.0 Days
Interval 1.0 to 368.0
19.0 Days
Interval 1.0 to 141.5
22.0 Days
Interval 1.0 to 376.0
19.0 Days
Interval 1.0 to 123.0

SECONDARY outcome

Timeframe: From the index date of first maintenance initiation until the initiation of the second maintenance therapy, up to 1020 days before this study started.

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018) initiated their second maintenance therapy and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.

Days between first and second maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy the United States (US) IBM MarketScan database were reported.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=7028 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=584 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=82 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=1813 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=1125 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=1834 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=1450 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=140 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Days Between First and Second Maintenance Therapy - US
160.0 Days
Interval 76.0 to 335.0
181.5 Days
Interval 89.5 to 339.5
176.0 Days
Interval 86.0 to 282.0
158.0 Days
Interval 74.0 to 321.0
223.0 Days
Interval 100.0 to 415.0
143.5 Days
Interval 70.0 to 314.0
137.0 Days
Interval 66.0 to 301.0
125.0 Days
Interval 67.0 to 266.5

SECONDARY outcome

Timeframe: From the index date of first maintenance initiation until the initiation of the second maintenance therapy, up to 10133 days before this study started.

Population: All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018) initiated their second maintenance therapy at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma prior to initiation of first maintenance therapy. Results were reported by overall and by stratified groups according to therapies.

Days between first and second maintenance therapy among chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.

Outcome measures

Outcome measures
Measure
US IBM Marketscan - COPD Diagnosis Before Tio+Olo Approval
n=2461 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=60 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
US IBM Marketscan - COPD Diagnosis After Tio+Olo Approval
n=101 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United States (US) IBM MarketScan database (contained data collected from January 1, 2008 to March 31, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 21 May 2015 were included in this group.
UK CPRD GOLD - Overall
n=338 Participants
All chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018).
UK CPRD GOLD - COPD Diagnosis Before Tio+Olo Approval
n=970 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD before the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
UK CPRD GOLD - COPD Diagnosis After Tio+Olo Approval
n=685 Participants
Cohort of chronic obstructive pulmonary disease (COPD) patients meeting all selection criteria from the United Kingdom (UK) CPRD GOLD database (contained data collected from November 21, 1987 to June 30, 2018). Only patients who were diagnosed COPD after the approval of Tiotropium + Olodaterol (Tio+Olo) in 1 July 2015 were included in this group.
US IBM Marketscan - 1MT - LAMA
n=222 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists (LAMA) were included in this group.
US IBM Marketscan - 1MT - LAMA+ICS
n=85 Participants
All chronic obstructive pulmonary disease (COPD) patients who meet all selection criteria from the United States (US) IBM MarketScan database initiated their first maintenance therapy (1MT) at the time of or after the launch date of Tiotropium + Olodaterol, and were free from asthma. Only patients who were treated with Long-Acting Muscarinic Antagonists + Inhaled Corticosteroid (LAMA+ICS) were included in this group
Days Between First and Second Maintenance Therapy - UK
218.0 Days
Interval 86.0 to 428.0
239.5 Days
Interval 61.5 to 528.0
141.0 Days
Interval 74.0 to 412.0
155.5 Days
Interval 67.0 to 335.0
284.0 Days
Interval 113.0 to 483.0
197.0 Days
Interval 82.0 to 397.0
225.5 Days
Interval 96.0 to 415.0
158.0 Days
Interval 71.0 to 281.0

Adverse Events

US IBM Marketscan - Overall

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

UK CPRD GOLD - Overall

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Results disclosure agreements

  • Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
  • Publication restrictions are in place

Restriction type: OTHER