Trial Outcomes & Findings for A Study Based on Medical Records That Looks at the Duration of Use of Two Types of Inhalers With Different Medicines in Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT03979807)
NCT ID: NCT03979807
Last Updated: 2021-11-15
Results Overview
The primary outcome of interest was discontinuation of index treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol), defined as persistence, (i.e. no refill Claim within 60 days \[not including treatment Switch, nor death\] after end of supply) during follow-up. Persistence was assessed by calculating rates of discontinuation in the matched cohorts using a 60-day allowable gap. Rates of discontinuation are reported as the number of events divided by the number of Person-years at risk. Addition of another treatment to index treatment did not count as discontinuation.
COMPLETED
11296 participants
From first day after the cohort entry date to the earliest occurence of the outcome (discontinuation or refills), or any censoring criteria (365 days of follow-up without discontinuation, death, disenrollment end of data).
2021-11-15
Participant Flow
The study compared the treatment persistence of patients with Chronic Obstructive Pulmonary Disease (COPD) using Olodaterol/Tiotropium Bromide inhaled via Respimat soft mist inhaler (SMI) versus patients with COPD using Umeclidinium/Vilanterol inhaled via the Ellipta Dry powder inhaler (DPI).
Only subjects that met all inclusion and none of the exclusion criteria were included in the study. Initiators of Olodaterol/Tiotropium Bromide were matched to patients receiving Umeclidinium/Vilanterol using a 1:2 propensity score matching, resulting in a matched cohort of 11296 overall.
Participant milestones
| Measure |
Olodaterol/Tiotropium Bromide - Matched Cohort
Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Olodaterol/Tiotropium Bromide (Stiolto®) delivered with the Respimat soft mist inhaler (SMI), within the Truven MarketScan database between November 2015 and March 2018.
|
Umeclidinium/Vilanterol - Matched Cohort
Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Umeclidinium/Vilanterol (Anoro®) delivered with the Ellipta dry powder Inhaler (DPI), within Truven MarketScan database between November 2015 and March 2018.
|
|---|---|---|
|
Overall Study
STARTED
|
3876
|
7420
|
|
Overall Study
COMPLETED
|
3876
|
7420
|
|
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 |
Olodaterol/Tiotropium Bromide - Matched Cohort
n=3876 Participants
Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Olodaterol/Tiotropium Bromide (Stiolto®) delivered with the Respimat soft mist inhaler (SMI), within the Truven MarketScan database between November 2015 and March 2018.
|
Umeclidinium/Vilanterol - Matched Cohort
n=7420 Participants
Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Umeclidinium/Vilanterol (Anoro®) delivered with the Ellipta dry powder Inhaler (DPI), within Truven MarketScan database between November 2015 and March 2018.
|
Total
n=11296 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.63 Years
STANDARD_DEVIATION 10.50 • n=3876 Participants
|
64.58 Years
STANDARD_DEVIATION 10.53 • n=7420 Participants
|
64.60 Years
STANDARD_DEVIATION 10.52 • n=11296 Participants
|
|
Sex: Female, Male
Female
|
1785 Participants
n=3876 Participants
|
3409 Participants
n=7420 Participants
|
5194 Participants
n=11296 Participants
|
|
Sex: Female, Male
Male
|
2091 Participants
n=3876 Participants
|
4011 Participants
n=7420 Participants
|
6102 Participants
n=11296 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: From first day after the cohort entry date to the earliest occurence of the outcome (discontinuation or refills), or any censoring criteria (365 days of follow-up without discontinuation, death, disenrollment end of data).Population: 1:2 propensity score matched cohort of initiators of Olodaterol/Tiotropium Bromide and initiators of Umeclidinium/Vilanterol, identified from Truven MarketScan Claims database between November 2015 and March 2018.
The primary outcome of interest was discontinuation of index treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol), defined as persistence, (i.e. no refill Claim within 60 days \[not including treatment Switch, nor death\] after end of supply) during follow-up. Persistence was assessed by calculating rates of discontinuation in the matched cohorts using a 60-day allowable gap. Rates of discontinuation are reported as the number of events divided by the number of Person-years at risk. Addition of another treatment to index treatment did not count as discontinuation.
Outcome measures
| Measure |
Olodaterol/Tiotropium Bromide - Matched Cohort
n=3876 Participants
Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Olodaterol/Tiotropium Bromide (Stiolto®) delivered with the Respimat soft mist inhaler (SMI), within the Truven MarketScan database between November 2015 and March 2018.
|
Umeclidinium/Vilanterol - Matched Cohort
n=7420 Participants
Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Umeclidinium/Vilanterol (Anoro®) delivered with the Ellipta dry powder Inhaler (DPI), within Truven MarketScan database between November 2015 and March 2018.
|
|---|---|---|
|
Rate of Discontinuation of Index Treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol)
|
1826.00 Events per 1000 person-years
|
1647.03 Events per 1000 person-years
|
Adverse Events
Olodaterol/Tiotropium Bromide - Matched Cohort
Umeclidinium/Vilanterol - Matched Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
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