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

NCT ID: NCT01580748

Last Updated: 2012-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Symptomatic Bronchiectasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment arm

single arm study

Group Type EXPERIMENTAL

Roflumilast

Intervention Type DRUG

500 microgram once daily for 16 weeks

Interventions

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Roflumilast

500 microgram once daily for 16 weeks

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hoil Yoon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam, Gyeongi-do, South Korea

Site Status

Countries

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South Korea

Central Contacts

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

Role: CONTACT

+82-31-787-7002

Facility Contacts

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Ho Il Yoon, M.D., Ph.D.

Role: primary

+82-31-787-7036

Other Identifiers

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B-1109-066-002

Identifier Type: -

Identifier Source: org_study_id

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