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)
The Role of Inhaler Device in the Treatment Persistence With Dual Bronchodilators in Patients With COPD
1 other identifier
observational
11,296
1 country
1
Brief Summary
To compare the persistence in using two different medications from the same drug class (LAMA/LABA FDC) which are delivered through different devices, a dry-powder inhalers (DPI) and Soft Mist Inhalers (SMI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2019
CompletedFirst Posted
Study publicly available on registry
June 7, 2019
CompletedStudy Start
First participant enrolled
June 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2019
CompletedResults Posted
Study results publicly available
July 23, 2020
CompletedNovember 15, 2021
November 1, 2021
1 day
June 6, 2019
June 8, 2020
November 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of Discontinuation of Index Treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol)
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.
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).
Study Arms (1)
Subjects with Chronic obstructive pulmonary disease
Interventions
(Stiolto®) delivered via Respimat inhaler
(Anoro®) delivered via Ellipta Inhaler
Eligibility Criteria
Patients initiating Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol up to 2.5 years
You may not qualify if:
- Aged \<40 years
- Enrolment with medical and pharmacy coverage prior to the cohort entry \< 180 days
- Never had COPD diagnosis on the cohort entry date or prior to cohort entry
- A record for dispensed Olodaterol/Tiotropium Bromide delivered with Respimat inhalator or Umeclidinium/Vilanterol delivered with the Ellipta Inhaler during the 180-day baseline prior to cohort entry
- Diagnosis of asthma any time prior to cohort entry
- Diagnosis of lung cancer any time prior to cohort entry
- Diagnosis of lung transplant any time prior to cohort entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aetion Inc.
New York, New York, 10018, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
By using data from insurance claims, data are based on a large, non-random convenience sample, which may contain biases or lack generalizability to other populations.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Centre
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2019
First Posted
June 7, 2019
Study Start
June 10, 2019
Primary Completion
June 11, 2019
Study Completion
June 11, 2019
Last Updated
November 15, 2021
Results First Posted
July 23, 2020
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing