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)

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

The Role of Inhaler Device in the Treatment Persistence With Dual Bronchodilators in Patients With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03979807
• Other study ID #: 1237-0090
• Status: Completed
• Start date: June 10, 2019
• Est. completion date: June 11, 2019

Study information

• Verified date: November 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11296
• Est. completion date: June 11, 2019
• Est. primary completion date: June 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 40 Years

Eligibility

Inclusion Criteria:

-

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Olodaterol/Tiotropium Bromide
(Stiolto®) delivered via Respimat inhaler
• Umeclidinium/ Vilanterol
(Anoro®) delivered via Ellipta Inhaler

Locations

Country	Name	City	State
United States	Aetion Inc.	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).

External Links

•   Related Info