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RETRIEVE: 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

Sponsor
Elpen Pharmaceutical Co. Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03858348
Collaborator
(none)
1,000
Enrollment
1
Location
8
Actual Duration (Months)
124.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1000 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    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
    Actual Study Start Date :
    May 1, 2019
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Dec 31, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    fluticasone / salmeterol treatment

    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

    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).

    Outcome Measures

    Primary Outcome Measures

    1. FEV1 [36 months]

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

    2. Exacerbations [36 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Papanikolaou Hospital of Thessaloniki Thessaloniki Greece

    Sponsors and Collaborators

    • Elpen Pharmaceutical Co. Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elpen Pharmaceutical Co. Inc.
    ClinicalTrials.gov Identifier:
    NCT03858348
    Other Study ID Numbers:
    • 2019-FLSAL-EL-94
    First Posted:
    Feb 28, 2019
    Last Update Posted:
    Apr 9, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pulmonary Disease, Chronic Obstructive
    Lung Diseases, Obstructive

    Study Results

    No Results Posted as of Apr 9, 2021