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COMPLETE: COMPLliancE and qualiTy of lifE in Asthma

Sponsor
Elpen Pharmaceutical Co. Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03300076
Collaborator
(none)
800
Enrollment
1
Location
10
Actual Duration (Months)
80.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A multicenter, open, non-interventional, prospective, clinical observational study on Conformity to Therapy and Quality of Life in Asthma in patients living in Greece

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Dry powder devices, available since 1970, have been developed to make inhalation simpler than pMDIs and relieve the need for co-ordination of spraying and inhalation, which is particularly important for patient groups such as the elderly and children. In addition, dry powder devices do not contain propellant gases potentially hostile to the environment as they are activated by inhalation of the patient and do not cause cold sensation upon inhalation.

    Today, the combination of inhaled corticosteroid (ICS) and long-acting β2-inducer with an inhaler is the basic treatment for asthma6.

    The addition of long-acting β2-inducer (LABA) to a daily inhaled corticosteroid regimen1:

    • Improves the symptoms,

    • Reduces nightly asthma symptoms,

    • Improves pulmonary function,

    • Reduces the use of β2-agonists for rapid action,

    • Reduces the number of seizures,

    • Does not increase the risk of hospitalizations due to asthma,

    • Achieves clinical asthma control in more patients, faster and with less ICS than would be required if ICS were administered alone.

    The greater effectiveness of combination therapy has led to the development of stable combination inhalers that both glucocorticosteroids and LABA (eg, fluticasone-salmeterol, budesonide-formoterol stable compounds) are concomitantly conveyed.

    Stable combinations are more user-friendly for patients, potentially increasing compliance, and ensure that LABA is always accompanied by glucocorticosteroid1. Of the combinations available, the budesonide-formoterol combination can be used both as maintenance therapy and symptom relief due to the rapid onset of formoterol compared to salmeterol. Both components of the budesonide-formoterol combination when administered are helpful in enhancing protection from severe seizures in patients receiving combination therapy for maintenance and improve the control of asthma at relatively low ICS doses.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    800 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Multicenter, Open-label, Non Interventional, Prospective, Observational Clinical Trial to Assess the Compliance and Quality of Life in Greek Asthmatic Patients
    Actual Study Start Date :
    Feb 1, 2018
    Actual Primary Completion Date :
    Dec 1, 2018
    Actual Study Completion Date :
    Dec 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Quality of Life [6 months]

      Change in mini AQLQ scale

    Secondary Outcome Measures

    1. Compliance [6 months]

      Change in MMAS-8 scale

    Eligibility Criteria

    Criteria

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

    • Male or female asthma patients over 18 years of age

    • Compliance with treatment

    • Compliance with study procedures

    • Signed informed consent form

    • Patients not satisfactorily controlled with inhaled corticosteroids and the use of inhaled short-acting β2-primers or patients already adequately controlled with both inhaled corticosteroids and long-acting β2-stimulants:

    1. Patients receiving ICS inhaled and SABA invoked

    2. Patients receiving inhaled ICS and LABA with separate devices each

    3. Patients receiving periodic and not continuously stable combination of ICS and LABA but not being treated for at least 1 month

    4. Patients who did not receive any treatment and the doctor decides to immediately start the fixed combination of ICS and LABA

    Exclusion Criteria:

    • Male or female asthma patients under 18 years of age

    • Unsigned patient consent

    • Non-compliance with treatment

    • Non-compliance in study procedures

    • COPD patients (at any stage)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sotiria Pulmonary 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:
    NCT03300076
    Other Study ID Numbers:
    • 2017-HAL-EL-74
    First Posted:
    Oct 3, 2017
    Last Update Posted:
    Dec 5, 2018
    Last Verified:
    Mar 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Dec 5, 2018