Phase2, Single Group, Open Clinical Trial to Evaluate the Efficacy and Safety of Roflumilast in Symptomatic Bronchiectasis Patients

• Status: Unknown status
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital

Criteria

Inclusion Criteria:

• Bronchiectasis on CT

• chronic (>3 months) cough or sputum

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)