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

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ClinicalTrials.gov Identifier: NCT01580748
Recruitment Status : Unknown
Verified April 2012 by Hoil Yoon, Seoul National University Bundang Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 19, 2012
Last Update Posted : April 19, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Symptomatic Bronchiectasis Drug: Roflumilast Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: Treatment arm
single arm study
Drug: Roflumilast
500 microgram once daily for 16 weeks


Outcome Measures

Primary Outcome Measures :
  1. change of CASA-Q score [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. change of FEV1 [ Time Frame: 16 weeks ]
  2. change of FVC [ Time Frame: 16 weeks ]
  3. alanine transaminase [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: April 19, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases