The Impact of Udenafil on Exercise Capacity in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT ID: NCT01364181

Last Updated: 2011-06-20

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-05-31

Brief Summary

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Pulmonary hypertension (PH) is a serious complication of COPD which is associated with shorter survival, more frequent exacerbation, and increased use of health resources. There is no effective pharmacological treatment for COPD-associated PH. Therefore, the investigators wanted to evaluate the effect of udenafil, a phosphodiesterase- 5 (PDE-5) inhibitor, on exercise capacity of severe COPD patients.

Detailed Description

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Study design

* prospective, single arm, open-label study
* Udenafil 50mg qd po for 8 weeks

Conditions

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Dyspnea Chronic Obstructive Pulmonary Disease Pulmonary Hypertension

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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Udenafil

Udenafil 50mg qd po

Group Type EXPERIMENTAL

Udenafil

Intervention Type DRUG

Udenafil 50mg qd po

Interventions

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Udenafil

Udenafil 50mg qd po

Intervention Type DRUG

Other Intervention Names

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Zydena

Eligibility Criteria

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Inclusion Criteria

* Severe COPD who showed post-bronchodilator forced expiratory volume in 1 second (FEV1) less than 50% of predicted value

Exclusion Criteria

* Acute exacerbation within 4 weeks of the study entry
* Coronary heart disease
* History of adverse event on PDE-5 inhibitors
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A PharmTech Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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Park JS, Lim HJ, Cho YJ, Lee JH, Yoon HI, Lee CT. Udenafil improves exercise capacity in patients with chronic obstructive pulmonary disease: a prospective study. COPD. 2012 Aug;9(5):499-504. doi: 10.3109/15412555.2012.694922. Epub 2012 Sep 4.

Reference Type DERIVED
PMID: 22946546 (View on PubMed)

Other Identifiers

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Udenafil

Identifier Type: -

Identifier Source: org_study_id

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