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

Sponsor
Seoul National University Bundang Hospital
Study ID
NCT01580748
Phase
PHASE2
Status
Unknown

Conditions

  • Symptomatic Bronchiectasis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    500 microgram once daily for 16 weeks

Study Details

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

Key Dates

Start date
May 31, 2012
Status verified
Apr 2012
Primary completion
Dec 31, 2012
Completion
Jan 31, 2013

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm
    single arm study

Primary Outcome Measure

change of CASA-Q score [ Time Frame: 16 weeks ]

Central Contacts