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Effects of Roxithromycin on Quality of Life and Physiological Outcomes in Bronchiectasis

Primary Purpose

Quality of Life, Respiratory Function Tests

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Roxithromycin 300 MG
Placebo
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life focused on measuring Bronchiectasis, quality of life, pulmonary function tests

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

minimum 15 year maximum 75 years

Criteria inclusion Criteria:

Symptomatic bronchiectasis Stable clinical bronchiectasis

Exclusion Criteria:

Adverse drug reaction to macrolide Recent exacerbation within 2 weeks History of macrolide therapy within 2 weeks active malignancy and end stage diseases 5. not perform lung function tests Females who were lactating

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    roxithromycin

    placebo

    Arm Description

    roxithromycin 300 mg oral per day

    placebo one tablet per day

    Outcomes

    Primary Outcome Measures

    SGRQ scores
    SGRQ scores

    Secondary Outcome Measures

    pulmonary function tests
    FEV1
    sputum volumes
    sputum volume per day

    Full Information

    First Posted
    October 8, 2019
    Last Updated
    October 10, 2019
    Sponsor
    Prince of Songkla University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04122040
    Brief Title
    Effects of Roxithromycin on Quality of Life and Physiological Outcomes in Bronchiectasis
    Official Title
    Effects of Roxithromycin on Quality of Life and Physiologic Outcomes in Bronchiectasis Patients During Treatment and Posttreatment Period
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2011 (Actual)
    Primary Completion Date
    September 30, 2011 (Actual)
    Study Completion Date
    September 30, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Prince of Songkla University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    roxithormycin 300 mg per day for 12 weeks could improve quality of life and physiological outcomes in bronchiectasis
    Detailed Description
    A randomized, double blinded, placebo controlled study was conducted to evaluate the effects of a 12-week administration of roxithromycin 300 mg once daily and a 12-week follow-up period in symptomatic stable bronchiectasis

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Quality of Life, Respiratory Function Tests
    Keywords
    Bronchiectasis, quality of life, pulmonary function tests

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomised control study
    Masking
    Investigator
    Masking Description
    block of 4
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    roxithromycin
    Arm Type
    Active Comparator
    Arm Description
    roxithromycin 300 mg oral per day
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    placebo one tablet per day
    Intervention Type
    Drug
    Intervention Name(s)
    Roxithromycin 300 MG
    Other Intervention Name(s)
    Roxithromycin
    Intervention Description
    Roxithromycin 300 mg oral per day
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo one table oral once dialy
    Primary Outcome Measure Information:
    Title
    SGRQ scores
    Description
    SGRQ scores
    Time Frame
    for 12 weeks
    Secondary Outcome Measure Information:
    Title
    pulmonary function tests
    Description
    FEV1
    Time Frame
    24 weeks
    Title
    sputum volumes
    Description
    sputum volume per day
    Time Frame
    24 wekse

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    minimum 15 year maximum 75 years Criteria inclusion Criteria: Symptomatic bronchiectasis Stable clinical bronchiectasis Exclusion Criteria: Adverse drug reaction to macrolide Recent exacerbation within 2 weeks History of macrolide therapy within 2 weeks active malignancy and end stage diseases 5. not perform lung function tests Females who were lactating
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kanung Saejiam, MS
    Organizational Affiliation
    Prince of Songkla University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    10445614
    Citation
    Nakamura H, Fujishima S, Inoue T, Ohkubo Y, Soejima K, Waki Y, Mori M, Urano T, Sakamaki F, Tasaka S, Ishizaka A, Kanazawa M, Yamaguchi K. Clinical and immunoregulatory effects of roxithromycin therapy for chronic respiratory tract infection. Eur Respir J. 1999 Jun;13(6):1371-9. doi: 10.1183/09031936.99.13613809.
    Results Reference
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    Effects of Roxithromycin on Quality of Life and Physiological Outcomes in Bronchiectasis

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