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

Primary Purpose

Dyspnea, Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Udenafil
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspnea focused on measuring Udenafil, Chronic obstructive pulmonary disease, pulmonary hypertension, Phosphodiesterase 5 inhibitors, Exercise, Dyspnea

Eligibility Criteria

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

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Udenafil

Arm Description

Udenafil 50mg qd po

Outcomes

Primary Outcome Measures

change of 6-minute walk distance

Secondary Outcome Measures

change of mean pulmonary artery pressure
change of lung function, SGRQ score, Borg index, oxygen saturation, mean pulmonary artery pressure

Full Information

First Posted
May 31, 2011
Last Updated
June 17, 2011
Sponsor
Seoul National University Hospital
Collaborators
Dong-A PharmTech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01364181
Brief Title
The Impact of Udenafil on Exercise Capacity in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
The Impact of Udenafil on Exercise Capacity in Severe COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital
Collaborators
Dong-A PharmTech Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
Study design prospective, single arm, open-label study Udenafil 50mg qd po for 8 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea, Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension
Keywords
Udenafil, Chronic obstructive pulmonary disease, pulmonary hypertension, Phosphodiesterase 5 inhibitors, Exercise, Dyspnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Udenafil
Arm Type
Experimental
Arm Description
Udenafil 50mg qd po
Intervention Type
Drug
Intervention Name(s)
Udenafil
Other Intervention Name(s)
Zydena
Intervention Description
Udenafil 50mg qd po
Primary Outcome Measure Information:
Title
change of 6-minute walk distance
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
change of mean pulmonary artery pressure
Description
change of lung function, SGRQ score, Borg index, oxygen saturation, mean pulmonary artery pressure
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho Il Yoon, M.D., Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22946546
Citation
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.
Results Reference
derived

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

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