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

Elpen Pharmaceutical Co. Inc.1,000 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

COPD COPD Exacerbation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion * Patients with COPD who started treatment with a fixed combination of fluticasone / salmeterol via the Elpenhaler® device after 01/01/2012 and were treated continuously for at least 1 year during the recording period. * Patients for whom spirometric data are available per monitoring year during recording. * Patients for whom exacerbation data are available per monitoring year during recording. Exclusion •Patients with asthma

Locations (1)

Outcomes

Primary Outcomes

FEV1

The rate of FEV1 change in patients in both groups A and B during the recording period.

Time frame: 36 months

Exacerbations

The number of exacerbations per year of patients in both groups A and B during the recording period.

Time frame: 36 months