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)

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Olodaterol/Tiotropium Bromide; Drug: Umeclidinium/ Vilanterol

• Registration Number: NCT03979807
• Lead Sponsor: Boehringer Ingelheim

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-06
• Study First Submitted QC: 2019-06-06
• Study First Posted: 2019-06-07
• Study Start: 2019-06-10
• Primary Completion: 2019-06-11
• Study Completion: 2019-06-11
• Results First Submitted: 2020-06-08
• Results First Submitted QC: 2020-07-08
• Results First Posted: 2020-07-23
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11296

Inclusion Criteria

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with Chronic obstructive pulmonary disease	Olodaterol/Tiotropium Bromide	-
Subjects with Chronic obstructive pulmonary disease	Umeclidinium/ Vilanterol	-

Primary Outcome Measures

Name	Time	Method
Rate of Discontinuation of Index Treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol)	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).	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.

Trial Locations

Locations (1)

Aetion Inc.; 🇺🇸 New York, New York, United States