Brief Title
Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis
Official Title
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 Phase
Phase 3
Study Type
Interventional
Primary Outcome
acute deterioration of of bronchiectasis symptoms
Secondary Outcome
Lung functions
Condition
Exacerbation Copd
Intervention
Roflumilast
Study Arms / Comparison Groups
Roflumilast
Description: Roflumilast 500 microgram one tab oral per day
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
January 2015
Completion Date
December 2015
Primary Completion Date
December 2015
Eligibility Criteria
Inclusion Criteria: - symptomatic Bronchiectasis - history at least 2 exacerbation last year Exclusion Criteria: - comorbidity with chronic obstructive pulmonary disease
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Kanung Saejiam, MS, ,
Location Countries
Thailand
Location Countries
Thailand
Administrative Informations
NCT ID
NCT04122547
Organization ID
25132558
Responsible Party
Principal Investigator
Study Sponsor
Prince of Songkla University
Study Sponsor
Kanung Saejiam, MS, Study Director, Prince of Songkla University
Verification Date
October 2019