Phase2, Single Group, Open Clinical Trial to Evaluate the... | NCT01580748

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

NCT01580748

Sponsor

Seoul National University Bundang Hospital

Status

Unknown status

Last Update Posted

Apr 19, 2012Estimated

Enrollment

25Estimated

Phase

Phase 2

Conditions

Symptomatic Bronchiectasis

Interventions

Roflumilast

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Dec 2012Estimated

Completion Date

Jan 2013Estimated

First Submitted Date

Apr 18, 2012

First Submission Date that Met QC Criteria

Apr 18, 2012

First Posted Date

Apr 19, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2012

Last Update Posted Date

Apr 19, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hoil Yoon, Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment arm	Experimental	single arm study	Drug: Roflumilast

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Roflumilast	Drug	500 microgram once daily for 16 weeks	Treatment arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of CASA-Q score		16 weeks

Secondary Outcomes

Measure	Description	Time Frame
change of FEV1		16 weeks
change of FVC		16 weeks
alanine transaminase

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Choon-Taek Lee, M.D., Ph.D.	Contact	+82-31-787-7002		ctlee@snubh.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam	Gyeongi-do	463-707	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
C424423	Roflumilast

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided