NCT03858348

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

A Retrospective rEal-life daTa Study to Assess the Incidence of exaceRbations and Change in Lung functIon Forced Expiratory Volume (FEV1) in Chronic Obstructive Pulmonary Disease ( COPD ) patiEnts receiVing Fluticasone/Salmeterol Fixed Dose Combination (FDC) Comparing to Those Εscalating in Open-triple Fluticasone/Salmeterol, Long Acting Muscarinic Antagonist (LAMA) Combination

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Elpen Pharmaceutical Co. Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COPD
• COPD Exacerbation

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2019-02-28
• Last updated: 2024-02-20

Locations

1 site across 1 country: Greece