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AHEAD: AdHerencE to Treatment and quAlity of Life in COPD

Sponsor
Elpen Pharmaceutical Co. Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03299673
Collaborator
(none)
600
Enrollment
1
Location
12.1
Actual Duration (Months)
49.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present non-interventional observational study in the Greek population aims at collecting the characteristics of COPD patients selected to be given the inhaled combination of fluticasone propionate and salmeterol in doses of 100 μg mcg (250 μg) mcg (500 g) mcg through the Elpenhaler® device, to investigate (a) the effectiveness of the treatment for compliance and the quality of life of the patients; and (b) the safety of the drugs in patients whose disease is treated either in a hospital or in a private physician.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Rolenium® is an inhalable combination the active ingredients of which is the inhaled combination of fluticasone propionate and salmeterol in doses (100 + 50) mcg, (250 + 50) mcg, (500 + 50) mcg administered via the Elpenhaler ®, developed by ELPEN. It has been approved as a bronchodilator therapy for COPD (a fast-exiting volume in the first second (FEV1) after a bronchodilator less than 60% predicted) with a history of repeated seizures that have significant symptoms despite regular bronchodilator therapy. For COPD in adults an inhalation of 500 micrograms of fluticasone propionate and 50 micrograms of salmeterol twice daily is recommended4. More information on the efficacy and safety of the investigational medicinal product is provided in the Summary of Product Characteristics (SPC).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    600 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Observational Study to Investigate the Compliance of Patients With COPD With the 8-item Morisky Medication Adherence Scale and Assessing the Quality of Life of Patients as Shown by the Clinical COPD Questionnaire (CCQ) Questionnaire.
    Actual Study Start Date :
    Dec 1, 2017
    Actual Primary Completion Date :
    Dec 5, 2018
    Actual Study Completion Date :
    Dec 5, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Quality of Life [3 months]

      Change in CCQ scale

    Secondary Outcome Measures

    1. Compliance [3 months]

      Change in MMAS-8 item scale

    Eligibility Criteria

    Criteria

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

    • Patients to be started on Rolenium®, an inhaled combination of fluticasone propionate and salmeterol in doses (100 + 50) mcg, (250 + 50) mcg, (500 + 50) mcg administered via the Elpenhaler®

    • Patients who should be diagnosed with severe COPD and FEV1 <60% of the expected normal rate and a history of repeated exacerbations that have significant symptoms despite regular bronchodilator therapy:

    1. Single LABA bronchoconstriction

    2. Under dual bronchoconstriction LABA / LAMA

    3. Never have received inhaled or systemic corticosteroids (ICS)

    4. Previous ICS use in the past may be present, as long as the patient is not in the same treatment for the last three months.

    • Male or female patients over 18 years of age

    • Compliance with treatment

    • Compliance with study procedures

    • Signed informed consent form

    Exclusion Criteria:

    • Men or women under 18 years of age

    • Non-compliance with treatment

    • Inappropriate use of inhaled therapies

    • Non-compliance in study procedures

    • Unsigned patient consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Evagelismos hospital Athens 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:
    NCT03299673
    Other Study ID Numbers:
    • 2017-HAL-EL-75
    First Posted:
    Oct 3, 2017
    Last Update Posted:
    Dec 5, 2018
    Last Verified:
    Sep 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive

    Study Results

    No Results Posted as of Dec 5, 2018