Comparative Effectiveness of COPD Treatments

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: LABA and the LAMA tiotropium (LABA-TIO); Drug: LABA and an ICS (LABA-ICS)

• Registration Number: NCT03376295
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease (COPD) with the combination of a long-acting bronchodilators (LABA and the long-acting muscarinic antagonists (LAMA) tiotropium (LABA-TIO)) compared with the combination of a LABA and an ICS (LABA-ICS) on the time to COPD exacerbation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-30
• Study Start: 2017-12-01
• Study First Submitted QC: 2017-12-13
• Study First Posted: 2017-12-18
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Results First Submitted: 2018-12-18
• Results First Submitted QC: 2019-04-17
• Status Verified: 2019-07
• Results First Posted: 2019-07-08
• Last Update Submitted: 2019-07-10
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3954

Inclusion Criteria

• New users of long-acting bronchodilators, LABA and tiotropium on the same date or of LABA and ICS, either as a fixed-dose combination or free combination, on the same date between January 2002 and December 2015
• Diagnosis of COPD and age ≥ 55 years

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Exclusion Criteria

• Less than one year of medical history information prior to the date of combined treatment initiation (cohort entry)
• Asthma diagnosis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects diagnosed with COPD	LABA and an ICS (LABA-ICS)	Chronic obstructive pulmonary disease
Subjects diagnosed with COPD	LABA and the LAMA tiotropium (LABA-TIO)	Chronic obstructive pulmonary disease

Primary Outcome Measures

Name	Time	Method
The Number of Observed Patients With First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation to Occur After Cohort Entry	12 Years	The number of observed patients with first COPD exacerbation after cohort entry was reported. The event of time to first COPD exacerbation to occur after cohort entry was defined as a hospitalization for COPD (severe exacerbation) or the prescription of an oral corticosteroid, namely prednisolone (moderate exacerbation) to occur after cohort entry with one-year follow-up, from the as-treated analysis.

Secondary Outcome Measures

Name	Time	Method
The Rate of COPD Exacerbations	12 years	Incidence rates and rate ratios of the moderate or severe exacerbation associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis, estimated.
The Occurrence of the First Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)	12 years	The number of the first occurences of the hospitalization for community-acquired pneumonia (serious pneumonia)associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis and from the time-dependent on-treatment analysis based on current exposure is presented. On-treatment exposure was based on analysis of current use during the entire 1-year follow-up, allowing patients to switch treatments.

Trial Locations

Locations (1)

Centre for Clinical Epidemiology, McGill University; 🇨🇦 Montreal, Canada