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Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis

Sponsor
Prince of Songkla University (Other)
Overall Status
Completed
CT.gov ID
NCT04122547
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
11
Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Roflumilast compare with placebo for decrease infected exacerbation in non-cystic Bronchiectasis

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Efficacy and RCT compare roflumilast vs placebo for 6 months in frequent infectious exacerbation in non-cystic bronchiectasis in Thailand

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis: a Randomized Double-blind Placebo-controlled Trial
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Roflumilast

Roflumilast 500 microgram one tab oral per day

Drug: Roflumilast
Active drug
Other Names:
  • Daxas

    		•
    Placebo Comparator: Placebo

    One tablet oral per day

    Drug: Placebo
    Placebo one tablet oral od

    Outcome Measures

    Primary Outcome Measures

    1. acute deterioration of of bronchiectasis symptoms [6 months]

      acute dyspnea worsening respiratory of symptoms

    Secondary Outcome Measures

    1. Lung functions [6 months]

      FEV1

    2. Exercise capacity [6 months]

      6 minute walk distance

    Other Outcome Measures

    1. Health related Quality of life [6 months]

      SGRQ scores, score range from 0-80, high score mean more symptoms

    Eligibility Criteria

    Criteria

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

    • symptomatic Bronchiectasis

    • history at least 2 exacerbation last year

    Exclusion Criteria:
    • comorbidity with chronic obstructive pulmonary disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Songklanagarind hospital Songkhla Thailand 90110

    Sponsors and Collaborators

    • Prince of Songkla University

    Investigators

    • Study Director: Kanung Saejiam, MS, Prince of Songkla University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Siwasak Juthong, Clinical Professor, Prince of Songkla University
    ClinicalTrials.gov Identifier:
    NCT04122547
    Other Study ID Numbers:
    • 25132558
    First Posted:
    Oct 10, 2019
    Last Update Posted:
    Oct 10, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Siwasak Juthong, Clinical Professor, Prince of Songkla University
    Bronchiectasis
    roflumilast
    exacerbation
    lung function
    Additional relevant MeSH terms:
    Bronchiectasis

    Study Results

    No Results Posted as of Oct 10, 2019