CompletedResults postedLast 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.
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 ExacerbationPrimary· 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.
Group
Value
95% CI
LABA-LAMA-ICS
3074
LABA-LAMA
630
Number of Participants Hospitalised With Moderate ExacerbationPrimary· 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.
Group
Value
95% CI
LABA-LAMA-ICS
2487
LABA-LAMA
542
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).
Group
Value
95% CI
LABA-LAMA-ICS
3099
LABA-LAMA
634
The Rate of COPD Exacerbations Over the One-year Follow-upSecondary· 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
Group
Value
95% CI
LABA-LAMA-ICS
94.4
LABA-LAMA
89.3
Severe exacerbation
Group
Value
95% CI
LABA-LAMA-ICS
13.4
LABA-LAMA
11.0
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.
Other recruiting trials for Pulmonary Disease, Chronic Obstructive
Currently open trials in the same condition.
NCT07177339 — eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (CO
· Phase 3
· recruiting
NCT06961214 — Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and T
· Phase 3
· recruiting
NCT06959095 — Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and T
· Phase 3
· recruiting
NCT06890208 — Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave
· recruiting
NCT06712563 — Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting
· recruiting
Other Boehringer Ingelheim trials
Trials by the same sponsor.
NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection
· not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a
· not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I
· Phase 3
· not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants
· Phase 1
· not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
· Phase 3
· not yet recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 3 December 2019
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.