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

Primary Purpose

Symptomatic Bronchiectasis

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Roflumilast
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Bronchiectasis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

single arm study

Outcomes

Primary Outcome Measures

change of CASA-Q score

Secondary Outcome Measures

change of FEV1
change of FVC
alanine transaminase

Full Information

First Posted
April 18, 2012
Last Updated
April 18, 2012
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01580748
Brief Title
Phase2, Single Group, Open Clinical Trial to Evaluate the Efficacy and Safety of Roflumilast in Symptomatic Bronchiectasis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Bronchiectasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm
Arm Type
Experimental
Arm Description
single arm study
Intervention Type
Drug
Intervention Name(s)
Roflumilast
Intervention Description
500 microgram once daily for 16 weeks
Primary Outcome Measure Information:
Title
change of CASA-Q score
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
change of FEV1
Time Frame
16 weeks
Title
change of FVC
Time Frame
16 weeks
Title
alanine transaminase
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Choon-Taek Lee, M.D., Ph.D.
Phone
+82-31-787-7002
Email
ctlee@snubh.org
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeongi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho Il Yoon, M.D., Ph.D.
Phone
+82-31-787-7036
Email
dextro@snubh.org

12. IPD Sharing Statement

Learn more about this trial

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

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