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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

Study Description
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Brief Summary:
Roflumilast compare with placebo for decrease infected exacerbation in non-cystic Bronchiectasis

Condition or disease Intervention/treatment Phase
Exacerbation Copd Bronchiectasis Lung Function Decreased Drug: Roflumilast Drug: Placebo 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
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Study Type : Interventional  (Clinical Trial)
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 : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Roflumilast

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Roflumilast
Roflumilast 500 microgram one tab oral per day
 Drug: Roflumilast
Active drug
Other Name: Daxas
Placebo Comparator: Placebo
One tablet oral per day
 Drug: Placebo
Placebo one tablet oral od


Outcome Measures
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Primary Outcome Measures :
  1. acute deterioration of of bronchiectasis symptoms [ Time Frame: 6 months ]
    acute dyspnea worsening respiratory of symptoms


Secondary Outcome Measures :
  1. Lung functions [ Time Frame: 6 months ]
    FEV1

  2. Exercise capacity [ Time Frame: 6 months ]
    6 minute walk distance


Other Outcome Measures:
  1. Health related Quality of life [ Time Frame: 6 months ]
    SGRQ scores, score range from 0-80, high score mean more symptoms


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • symptomatic Bronchiectasis
  • history at least 2 exacerbation last year

Exclusion Criteria:

  • comorbidity with chronic obstructive pulmonary disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122547


Locations
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Thailand
Songklanagarind hospital
Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
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Study Director: Kanung Saejiam, MS Prince of Songkla University
More Information
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Responsible Party: Siwasak Juthong, Clinical Professor, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT04122547    
Other Study ID Numbers: 25132558
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Siwasak Juthong, Prince of Songkla University:
Bronchiectasis
roflumilast
exacerbation
lung function
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases