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Survey on the Effect of Health Related Quality of Life (QOL) Associated With Compliance of Carbocisteine in Asthma Patients

Sponsor
Kyorin Pharmaceutical Co.,Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT01693471
Collaborator
(none)
179
Enrollment
1
Location
4
Duration (Months)
44.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objectives of this study are to investigate the influence on HR-QOL (SF-36 v2) resulting from the compliance of MUCODYNE Tablets or MUCODYNE DS (Dry Syrup) 50% in asthma patients whose control levels are partly controlled or uncontrolled.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Period: 2012-2013 Observation Time: 0 week, 4 week

    Matters investigated:

    1. QOL determination using SF-36 v2

    2. Medication compliance (VAS scale)

    3. Gender, age, diagnosis, asthma subtype, severity, duration of disease, level of asthma control, concomitant drugs, comorbidities, smoking, alcohol, work

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    179 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Survey on the Effect of Health Related QOL Associated With Compliance of Carbocisteine in Asthma Patients Study (SEARCH Study)
    Study Start Date :
    Sep 1, 2012
    Actual Primary Completion Date :
    Dec 1, 2012
    Actual Study Completion Date :
    Jan 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    SEARCH Study Group

    Outcome Measures

    Primary Outcome Measures

    1. Score of SF-36 [4 week]

    Secondary Outcome Measures

    1. HR-QOL condition of asthma patients with phlegm [0 week]

    2. Medication compliance: measured by patient response to visual analog scale [4 week]

    3. Relation between a medication compliance measured by patient response to visual analog scale and change of HR-QOL from baseline at 4 weeks [0 week, 4 week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male and female patients ≥ 20 years of age

    • Outpatients

    • Patients with mild or moderate persistent asthma

    • Patients with phlegm

    • Patients whose levels of asthma control are partly controlled or uncontrolled

    • Patients who are planned to treat MUCODYNE

    • Patients who voluntarily submitted written consent forms upon participation in this study

    Exclusion Criteria:

    • Patients with a history of adverse reactions to carbocisteine

    • Patients with serious cardiac, hepatic, renal, pulmonary, or hematological disease

    • Patients with the possibility of pregnancy or suspected pregnancy

    • Patients with complication of malignancy

    • Current smoker

    • Patients with definitive diagnosis for COPD

    • Other patients whom investigators or subinvestigators considered inappropriate to participate in this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Senzoku Respiratory Disease and Allergy Clinic Ota-ku Tokyo Japan 145-0063

    Sponsors and Collaborators

    • Kyorin Pharmaceutical Co.,Ltd

    Investigators

    • Study Chair: Akito Saegusa, Mr., Kyorin Pharmaceutical Co.,Ltd

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kyorin Pharmaceutical Co.,Ltd
    ClinicalTrials.gov Identifier:
    NCT01693471
    Other Study ID Numbers:
    • SEARCH-2012
    First Posted:
    Sep 26, 2012
    Last Update Posted:
    Mar 1, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Kyorin Pharmaceutical Co.,Ltd
    asthma
    SF-36
    HRQOL
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Mar 1, 2013