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

This study is not yet open for participant recruitment.
Verified April 2012 by Seoul National University Bundang Hospital
Sponsor:
Information provided by (Responsible Party):
Hoil Yoon, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01580748
First received: April 18, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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


Condition Intervention Phase
Symptomatic Bronchiectasis
 Drug: Roflumilast
 Phase 2

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

Resource links provided by NLM:

Drug Information available for: Roflumilast
U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • change of CASA-Q score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change of FEV1 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • change of FVC [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • alanine transaminase [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: May 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm
single arm study
 Drug: Roflumilast
500 microgram once daily for 16 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580748

Contacts
Contact: Choon-Taek Lee, M.D., Ph.D. +82-31-787-7002 ctlee@snubh.org

Locations
Korea, Republic of
Seoul National University Bundang Hospital Not yet recruiting
Seongnam, Gyeongi-do, Korea, Republic of, 463-707
Contact: Ho Il Yoon, M.D., Ph.D.     +82-31-787-7036     dextro@snubh.org    
Sponsors and Collaborators
Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Hoil Yoon, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01580748     History of Changes
Other Study ID Numbers: B-1109-066-002
Study First Received: April 18, 2012
Last Updated: April 18, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013