N/A
N=3,954
Comparative Effectiveness of COPD Treatments
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT03376295 ↗Enrolled (actual)
3,954
Serious AEs
—
Results posted
Jul 2019
Primary outcome: Primary: The Number of Observed Patients With First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation to Occur After Cohort Entry — 344; 412; 55; 60 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- LABA and the LAMA tiotropium (LABA-TIO) (Drug); LABA and an ICS (LABA-ICS) (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Observed Patients With First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation to Occur After Cohort Entry |
344; 412; 55; 60 | — |
| SECONDARY The Rate of COPD Exacerbations |
0.83; 0.91; 0.13; 0.11 | — |
| SECONDARY The Occurrence of the First Hospitalization for Community-acquired Pneumonia (Serious Pneumonia) |
41; 32; 143; 49 | — |
Summary
To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease (COPD) with the combination of a long-acting bronchodilators (LABA and the long-acting muscarinic antagonists (LAMA) tiotropium (LABA-TIO)) compared with the combination of a LABA and an ICS (LABA-ICS) on the time to COPD exacerbation.
Eligibility Criteria
Inclusion Criteria
- New users of long-acting bronchodilators, LABA and tiotropium on the same date or of LABA and ICS, either as a fixed-dose combination or free combination, on the same date between January 2002 and December 2015
- Diagnosis of COPD and age ≥ 55 years
Exclusion Criteria
- Less than one year of medical history information prior to the date of combined treatment initiation (cohort entry)
- Asthma diagnosis
Data sourced from ClinicalTrials.gov (NCT03376295). 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.