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NCT03724877

Effectiveness of Triple Therapy in COPD

Completed Results posted Last updated 3 December 2019
What this trial tests

trial testing Long-acting beta2-agonist-long-acting muscarinic antagonists-inhaled corticosteroids(LABA-LAMA-ICS) in Pulmonary Disease, Chronic Obstructive in 8,853 participants. Completed in 12 November 2018.

Timeline
10 November 2018
Primary endpoint
12 November 2018
12 November 2018

Quick facts

Lead sponsorBoehringer Ingelheim
StatusCompleted
Study typeOBSERVATIONAL
Enrollment8,853
Start date10 November 2018
Primary completion12 November 2018
Estimated completion12 November 2018
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

55 and older, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Hospitalised With Severe Exacerbation Primary · 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.

GroupValue95% CI
LABA-LAMA-ICS3074
LABA-LAMA630
Number of Participants Hospitalised With Moderate Exacerbation Primary · 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.

GroupValue95% CI
LABA-LAMA-ICS2487
LABA-LAMA542
Number of Participants Hospitalised With Community-acquired Pneumonia (Serious Pneumonia) Primary · 1 year

The primary outcome event for safety was the occurrence of the first hospitalization for community-acquired pneumonia (serious pneumonia).

GroupValue95% CI
LABA-LAMA-ICS3099
LABA-LAMA634
The Rate of COPD Exacerbations Over the One-year Follow-up Secondary · 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.

Moderate/ sever exacerbation
GroupValue95% CI
LABA-LAMA-ICS94.4
LABA-LAMA89.3
Severe exacerbation
GroupValue95% CI
LABA-LAMA-ICS13.4
LABA-LAMA11.0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Pulmonary Disease, Chronic Obstructive

Currently open trials in the same condition.

Other Boehringer Ingelheim trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03724877.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing