Phase2, Single Group, Open Clinical Trial to Evaluate the Efficacy and Safety of Roflumilast in Symptomatic Bronchiectasis Patients
- Registration Number
- NCT01580748
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
There is currently no effective treatment of bronchiectasis other than treating its complications such as infection, bleeding, etc. Roflumilast is a newly developed anti-inflammatory drug that has proven to be effective in stable COPD. We hypothesized that Roflumilast might be effective in symptomatic bronchiectasis patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Bronchiectasis on CT
- chronic (>3 months) cough or sputum
Read More
Exclusion Criteria
- needs hospitalization
- life expectancy of less than six months
- pregnancy or breast feeding
- history of acute respiratory infection within 4 weeks
- history of taking antibiotics within 4 weeks
- active hemoptysis
- %predicted FEV < 30%
- severe liver disease (Child Pugh Class B or C)
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment arm Roflumilast single arm study
- Primary Outcome Measures
Name Time Method change of CASA-Q score 16 weeks
- Secondary Outcome Measures
Name Time Method alanine transaminase 4 weeks change of FEV1 16 weeks change of FVC 16 weeks
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeongi-do, Korea, Republic of