Comparative Effectiveness of Triple Therapy in COPD: A New-user Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Long-acting beta2-agonist-long-acting muscarinic antagonists-inhaled corticosteroids(LABA-LAMA-ICS)
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 8853
- Locations
- 1
- Primary Endpoint
- Number of Participants Hospitalised With Moderate Exacerbation
- 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 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.
Investigators
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
- •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
Arms & Interventions
Subjects with Chronic obstructive pulmonary disease (COPD)
Intervention: Long-acting beta2-agonist-long-acting muscarinic antagonists-inhaled corticosteroids(LABA-LAMA-ICS)
Subjects with Chronic obstructive pulmonary disease (COPD)
Intervention: Long-acting beta2-agonist-inhaled corticosteroids-long-acting muscarinic antagonists (LABA-LAMA)
Outcomes
Primary Outcomes
Number of Participants Hospitalised With Moderate Exacerbation
Time Frame: 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.
Number of Participants Hospitalised With Community-acquired Pneumonia (Serious Pneumonia)
Time Frame: 1 year
The primary outcome event for safety was the occurrence of the first hospitalization for community-acquired pneumonia (serious pneumonia).
Number of Participants Hospitalised With Severe Exacerbation
Time Frame: 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.
Secondary Outcomes
- The Rate of COPD Exacerbations Over the One-year Follow-up(1 year)