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

Seoul National University

Status and phase: Unknown; Phase 2

Conditions: Symptomatic Bronchiectasis

Treatments: Drug: Roflumilast

Study type: Interventional

Funder types: Other

Identifiers

NCT01580748

B-1109-066-002

Details and patient eligibility

About

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

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Treatment arm

Experimental group

Description:

single arm study

Treatment:

Drug: Roflumilast