N/A
N=8,853
Effectiveness of Triple Therapy in COPD
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT03724877 ↗Enrolled (actual)
8,853
Serious AEs
—
Results posted
Dec 2019
Primary outcome: Primary: Number of Participants Hospitalised With Severe Exacerbation — 3074; 630 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 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) (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Nov 2018
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 | — |
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.
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.