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

Tracking Information

First Received Date ^ICMJE

April 18, 2012

Last Updated Date

April 18, 2012

Start Date ^ICMJE

May 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Symptomatic Bronchiectasis

Intervention ^ICMJE

Drug: Roflumilast

500 microgram once daily for 16 weeks

Study Arm (s)

Experimental: Treatment arm

single arm study

Intervention: Drug: Roflumilast

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Choon-Taek Lee, M.D., Ph.D.

+82-31-787-7002

ctlee@snubh.org

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01580748

Other Study ID Numbers ^ICMJE

B-1109-066-002

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoil Yoon, Seoul National University Bundang Hospital

Study Sponsor ^ICMJE

Seoul National University Bundang Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Seoul National University Bundang Hospital

Verification Date

April 2012

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

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