This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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
Information provided by (Responsible Party):
Hoil Yoon, Seoul National University Bundang Hospital Identifier:
First received: April 18, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

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

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

Secondary Outcome Measures:
  • change of FEV1 [ Time Frame: 16 weeks ]
  • change of FVC [ Time Frame: 16 weeks ]
  • alanine transaminase [ Time Frame: 4 weeks ]

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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01580748

Contact: Choon-Taek Lee, M.D., Ph.D. +82-31-787-7002

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   
Sponsors and Collaborators
Seoul National University Bundang Hospital
  More Information

Responsible Party: Hoil Yoon, Professor, Seoul National University Bundang Hospital Identifier: NCT01580748     History of Changes
Other Study ID Numbers: B-1109-066-002
Study First Received: April 18, 2012
Last Updated: April 18, 2012

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases processed this record on September 20, 2017