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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Seoul National University Bundang Hospital.
Recruitment status was  Not yet recruiting
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

April 18, 2012
April 18, 2012
May 2012
December 2012   (final data collection date for primary outcome measure)
change of CASA-Q score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Phase2, Single Group, Open Clinical Trial to Evaluate the Efficacy and Safety of Roflumilast in Symptomatic Bronchiectasis Patients
Not Provided

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Symptomatic Bronchiectasis
Drug: Roflumilast
500 microgram once daily for 16 weeks
Experimental: Treatment arm
single arm study
Intervention: Drug: Roflumilast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
25
January 2013
December 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact: Choon-Taek Lee, M.D., Ph.D. +82-31-787-7002 ctlee@snubh.org
Korea, Republic of
 
NCT01580748
B-1109-066-002
Not Provided
Hoil Yoon, Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
Not Provided
Not Provided
Seoul National University Bundang Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP