Trial Outcomes & Findings for Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to Triple Therapy (NCT NCT04184297)
NCT ID: NCT04184297
Last Updated: 2021-11-15
Results Overview
Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrence of a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation).
COMPLETED
27190 participants
From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry.
2021-11-15
Participant Flow
The study investigate the effectiveness and safety of maintenance treatment with combination of tiotropium and olodaterol comparing to maintenance treatment with combination of inhaled corticosteroids in patients with chronic obstructive pulmonary disease (COPD) based on existing data.
The study was conducted using existing administrative healthcare claims and laboratory result data captured in the HealthCore Integrated Research Database (HIRD). The observation period was from January 2013 until the most recent date available at the time that the cohort is extracted (March 2019).
Participant milestones
| Measure |
Tiotropium+Olodaterol
All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Tiotropium+Olodaterol (Tio + Olo) treatment from 1 January 2013 until 31 March 2019.
|
LABA/LAMA/ICS
All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Long-acting beta2-agonist (LABA) / Long-acting muscarinic antagonists (LAMA) / Inhaled corticosteroids (ICS) treatment from 1 January 2013 until 31 March 2019.
|
|---|---|---|
|
Overall Study
STARTED
|
2864
|
24326
|
|
Overall Study
COMPLETED
|
2864
|
24326
|
|
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
| Measure |
Tiotropium+Olodaterol
n=2864 Participants
All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Tiotropium+Olodaterol (Tio + Olo) treatment from 1 January 2013 until 31 March 2019.
|
LABA/LAMA/ICS
n=24326 Participants
All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Long-acting beta2-agonist (LABA) / Long-acting muscarinic antagonists (LAMA) / Inhaled corticosteroids (ICS) treatment from 1 January 2013 until 31 March 2019.
|
Total
n=27190 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.4 Years
STANDARD_DEVIATION 10.5 • n=2864 Participants
|
66.8 Years
STANDARD_DEVIATION 10.7 • n=24326 Participants
|
66.7 Years
STANDARD_DEVIATION 10.7 • n=27190 Participants
|
|
Sex: Female, Male
Female
|
1349 Participants
n=2864 Participants
|
11701 Participants
n=24326 Participants
|
13050 Participants
n=27190 Participants
|
|
Sex: Female, Male
Male
|
1515 Participants
n=2864 Participants
|
12625 Participants
n=24326 Participants
|
14140 Participants
n=27190 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry.Population: Patients with Chronic Obstructive Pulmonary Disease (COPD) from HealthCore Integrated Research Database (January 2013 - March 2019) that meet all inclusion criteria, with laboratory result data available and non-missing endpoint outcomes.
Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrence of a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation).
Outcome measures
| Measure |
Tiotropium+Olodaterol
n=2864 Participants
All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Tiotropium+Olodaterol (Tio + Olo) treatment from 1 January 2013 until 31 March 2019.
|
LABA/LAMA/ICS
n=24326 Participants
All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Long-acting beta2-agonist (LABA) / Long-acting muscarinic antagonists (LAMA) / Inhaled corticosteroids (ICS) treatment from 1 January 2013 until 31 March 2019.
|
|---|---|---|
|
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
|
1.32 Events per 1000 person-days
Interval 1.19 to 1.48
|
1.14 Events per 1000 person-days
Interval 1.1 to 1.18
|
PRIMARY outcome
Timeframe: From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry.Population: Patients with Chronic Obstructive Pulmonary Disease (COPD) from HealthCore Integrated Research Database (January 2013 - March 2019) that meet all inclusion criteria, and non-missing endpoint outcomes. Participants with exacerbation within 30 days prior to cohort entry were excluded.
Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation excluding participants who had exacerbation within 30 days prior to cohort entry, was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrenceof a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation).
Outcome measures
| Measure |
Tiotropium+Olodaterol
n=2591 Participants
All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Tiotropium+Olodaterol (Tio + Olo) treatment from 1 January 2013 until 31 March 2019.
|
LABA/LAMA/ICS
n=18352 Participants
All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Long-acting beta2-agonist (LABA) / Long-acting muscarinic antagonists (LAMA) / Inhaled corticosteroids (ICS) treatment from 1 January 2013 until 31 March 2019.
|
|---|---|---|
|
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry
|
1.18 Events per 1000 person-days
Interval 1.05 to 1.33
|
0.99 Events per 1000 person-days
Interval 0.95 to 1.03
|
SECONDARY outcome
Timeframe: From cohort entry (index date) until the occurrence of hospitalization for community-acquired pneumonia (serious pneumonia). Up to 1 year after cohort entry.Population: Patients with Chronic Obstructive Pulmonary Disease (COPD) from HealthCore Integrated Research Database (January 2013 - March 2019) that meet all inclusion criteria, with laboratory result data available and non-missing endpoint outcomes.
Overall incidence rate of first hospitalization for community-acquired pneumonia (serious pneumonia).
Outcome measures
| Measure |
Tiotropium+Olodaterol
n=2864 Participants
All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Tiotropium+Olodaterol (Tio + Olo) treatment from 1 January 2013 until 31 March 2019.
|
LABA/LAMA/ICS
n=24326 Participants
All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Long-acting beta2-agonist (LABA) / Long-acting muscarinic antagonists (LAMA) / Inhaled corticosteroids (ICS) treatment from 1 January 2013 until 31 March 2019.
|
|---|---|---|
|
Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)
|
0.25 Events per 1000 person-days
Interval 0.2 to 0.32
|
0.24 Events per 1000 person-days
Interval 0.22 to 0.25
|
Adverse Events
Tiotropium+Olodaterol
LABA/LAMA/ICS
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place