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

Symptomatic Bronchiectasis Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01580748
• Other study ID #: B-1109-066-002
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 18, 2012
• Last updated: April 18, 2012
• Start date: May 2012
• Est. completion date: January 2013

Study information

• Verified date: April 2012
• Source: Seoul National University Bundang Hospital
• Contact: Choon-Taek Lee, M.D., Ph.D.
• Phone: +82-31-787-7002
• Email: ctlee[@]snubh.org
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis
• Symptomatic Bronchiectasis

Intervention

Drug:
• Roflumilast
500 microgram once daily for 16 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeongi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of CASA-Q score		16 weeks	No
Secondary	change of FEV1		16 weeks	No
Secondary	change of FVC		16 weeks	No
Secondary	alanine transaminase		4 weeks	Yes