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 (RETRIEVE)

ELPEN

Status: Completed

Conditions: COPD; COPD Exacerbation

Study type: Observational

Funder types: Industry

Identifiers

NCT03858348

2019-FLSAL-EL-94

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

1,000 participants in 2 patient groups

fluticasone / salmeterol treatment

Description:

The evaluation of pulmonary function in patients with COPD receiving and maintaining a stable combination of fluticasone / salmeterol (Group A)

fluticasone / salmeterol and extra LAMA

Description:

The evaluation of pulmonary function in patients with COPD receiving and maintaining a stable combination of fluticasone / salmeterol and extra a long-acting muscarinic receptor antagonist (anticholinergic, LAMA) (Group B).