A Retrospective rEal-life daTa Study to Assess the exaceRbations and Lung functIon in Chronic Obstructive Pulmonary Disease ( COPD ) patiEnts receiVing Fluticasone/Salmeterol Comparing to Those Εscalating in Open-triple Fluticasone/Salmeterol, Long Acting Muscarinic Antagonist (LAMA) Combination
- Conditions
- COPDCOPD Exacerbation
- Registration Number
- NCT03858348
- Lead Sponsor
- Elpen Pharmaceutical Co. Inc.
- Brief Summary
Inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) combination is commonly prescribed to treat COPD; we will perform a retrospective analysis on the effect of adding a long-acting muscarinic receptor antagonist (LAMA) to ICS/LABA combination in COPD.
- Detailed Description
According to the current guidelines for the treatment of COPD, it is recommended to use combination therapies with different or complementary mechanisms of action . Data suggest that open triple therapy incorporating LAMA with ICS / LABA combination products administered through different delivery devices may be beneficial for improving pulmonary function in patients with COPD. However, there is little evidence of the effect of triple therapy on pulmonary function and the incidence of exacerbations in COPD patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method FEV1 36 months The rate of FEV1 change in patients in both groups A and B during the recording period.
Exacerbations 36 months The number of exacerbations per year of patients in both groups A and B during the recording period.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Papanikolaou Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece