N/A
Completed N=8,853
Effectiveness of Triple Therapy in COPD
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT03724877 ↗
Enrolled (actual)
8,853
Serious AEs
—
Results posted
Dec 2019
Primary outcomePrimary: Number of Participants Hospitalised With Severe Exacerbation — 3074; 630 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Hospitalised With Severe Exacerbation |
3074; 630 | — |
| PRIMARY Number of Participants Hospitalised With Moderate Exacerbation |
2487; 542 | — |
| PRIMARY Number of Participants Hospitalised With Community-acquired Pneumonia (Serious Pneumonia) |
3099; 634 | — |
| SECONDARY The Rate of COPD Exacerbations Over the One-year Follow-up |
94.4; 89.3; 13.4; 11.0 | — |
Eligibility Criteria
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.
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
Data sourced from ClinicalTrials.gov (NCT03724877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.