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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. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Hoil Yoon, Seoul National University Bundang Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01580748
First Posted: April 19, 2012
Last Update Posted: April 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoil Yoon, Seoul National University Bundang Hospital
April 18, 2012
April 19, 2012
April 19, 2012
May 2012
December 2012   (Final data collection date for primary outcome measure)
change of CASA-Q score [ Time Frame: 16 weeks ]
Same as current
No Changes Posted
  • change of FEV1 [ Time Frame: 16 weeks ]
  • change of FVC [ Time Frame: 16 weeks ]
  • alanine transaminase [ Time Frame: 4 weeks ]
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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Unknown status
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)
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01580748
B-1109-066-002
Not Provided
Not Provided
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