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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04122547
Recruitment Status : Completed
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Siwasak Juthong, Prince of Songkla University

Tracking Information
First Submitted Date  ICMJE October 8, 2019
First Posted Date  ICMJE October 10, 2019
Last Update Posted Date October 10, 2019
Study Start Date  ICMJE January 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
acute deterioration of of bronchiectasis symptoms [ Time Frame: 6 months ]
acute dyspnea worsening respiratory of symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
  • Lung functions [ Time Frame: 6 months ]
    FEV1
  • Exercise capacity [ Time Frame: 6 months ]
    6 minute walk distance
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 9, 2019)
Health related Quality of life [ Time Frame: 6 months ]
SGRQ scores, score range from 0-80, high score mean more symptoms
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis
Official Title  ICMJE Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis: a Randomized Double-blind Placebo-controlled Trial
Brief Summary Roflumilast compare with placebo for decrease infected exacerbation in non-cystic Bronchiectasis
Detailed Description Efficacy and RCT compare roflumilast vs placebo for 6 months in frequent infectious exacerbation in non-cystic bronchiectasis in Thailand
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Exacerbation Copd
  • Bronchiectasis
  • Lung Function Decreased
Intervention  ICMJE
  • Drug: Roflumilast
    Active drug
    Other Name: Daxas
  • Drug: Placebo
    Placebo one tablet oral od
Study Arms  ICMJE
  • Active Comparator: Roflumilast
    Roflumilast 500 microgram one tab oral per day
    Intervention: Drug: Roflumilast
  • Placebo Comparator: Placebo
    One tablet oral per day
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2019)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • symptomatic Bronchiectasis
  • history at least 2 exacerbation last year

Exclusion Criteria:

  • comorbidity with chronic obstructive pulmonary disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04122547
Other Study ID Numbers  ICMJE 25132558
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Siwasak Juthong, Prince of Songkla University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Prince of Songkla University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kanung Saejiam, MS Prince of Songkla University
PRS Account Prince of Songkla University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP