Effectiveness of Triple Therapy in COPD

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Long-acting beta2-agonist-long-acting muscarinic antagonists-inhaled corticosteroids(LABA-LAMA-ICS); Drug: Long-acting beta2-agonist-inhaled corticosteroids-long-acting muscarinic antagonists (LABA-LAMA)

• Registration Number: NCT03724877
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease (COPD) with the Long-acting beta2-agonist - long-acting muscarinic antagonists-inhaled corticosteroids (LABA-LAMA-ICS) combination with a LABA-LAMA combination on the risk of COPD exacerbation and the safety on the incidence of community acquired pneumonia.

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: 2018-10-29
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-30
• Study Start: 2018-11-10
• Primary Completion: 2018-11-12
• Study Completion: 2018-11-12
• Status Verified: 2019-11
• Results First Submitted: 2019-11-11
• Results First Submitted QC: 2019-11-29
• Last Update Submitted: 2019-11-29
• Results First Posted: 2019-12-03
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8853

Inclusion Criteria

• New users of long-acting bronchodilators, Long-acting beta2-agonist (LABA) and long-acting muscarinic antagonists (LAMA) on the same date or of LABA, LAMA and inhaled corticosteroids (ICS), either as a fixed-dose combination (LABA-ICS) or free combination, on the same date between January 2002 and December 2016.
• Diagnosis of Chronic obstructive pulmonary disease (COPD) prior to first maintenance inhaler and age ≥ 55 years at first maintenance inhaler.

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Exclusion Criteria

• Less than one year of medical history information prior to the date of combined treatment initiation (study cohort entry)
• Asthma diagnosis prior to study 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 (COPD)	Long-acting beta2-agonist-inhaled corticosteroids-long-acting muscarinic antagonists (LABA-LAMA)	-
Subjects with Chronic obstructive pulmonary disease (COPD)	Long-acting beta2-agonist-long-acting muscarinic antagonists-inhaled corticosteroids(LABA-LAMA-ICS)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Hospitalised With Moderate Exacerbation	1 year	The primary outcome event for effectiveness was the first COPD exacerbation to occur after cohort entry. The event was defined as a hospitalization with the prescription of an oral corticosteroid, namely prednisolone (moderate exacerbation) is presented.
Number of Participants Hospitalised With Community-acquired Pneumonia (Serious Pneumonia)	1 year	The primary outcome event for safety was the occurrence of the first hospitalization for community-acquired pneumonia (serious pneumonia).
Number of Participants Hospitalised With Severe Exacerbation	1 year	The primary outcome event for effectiveness was the first COPD exacerbation to occur after cohort entry. The event was defined as a hospitalization with a primary diagnosis of COPD (severe exacerbation) is presented.

Secondary Outcome Measures

Name	Time	Method
The Rate of COPD Exacerbations Over the One-year Follow-up	1 year	This outcome was based on the number of hospitalizations and on the number of courses of treatment with an oral corticosteroid. A gap of at least 30 days between treatment courses was required to consider the exacerbations as separate events.

Trial Locations

Locations (1)

Clinical Practice Research Datalink; 🇬🇧 London, United Kingdom