Comparative Effectiveness of Combination Therapies in COPD
Overview
- Phase
- Not Applicable
- Intervention
- LABA and an ICS (LABA-ICS)
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 3954
- Locations
- 1
- Primary Endpoint
- The Number of Observed Patients With First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation to Occur After Cohort Entry
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
Subjects diagnosed with COPD
Chronic obstructive pulmonary disease
Intervention: LABA and an ICS (LABA-ICS)
Subjects diagnosed with COPD
Chronic obstructive pulmonary disease
Intervention: LABA and the LAMA tiotropium (LABA-TIO)
Outcomes
Primary Outcomes
The Number of Observed Patients With First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation to Occur After Cohort Entry
Time Frame: 12 Years
The number of observed patients with first COPD exacerbation after cohort entry was reported. The event of time to first COPD exacerbation to occur after cohort entry was defined as a hospitalization for COPD (severe exacerbation) or the prescription of an oral corticosteroid, namely prednisolone (moderate exacerbation) to occur after cohort entry with one-year follow-up, from the as-treated analysis.
Secondary Outcomes
- The Rate of COPD Exacerbations(12 years)
- The Occurrence of the First Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)(12 years)