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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01364181
Recruitment Status : Completed
First Posted : June 2, 2011
Last Update Posted : June 20, 2011
Dong-A PharmTech Co., Ltd.
Information provided by:
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Dyspnea Chronic Obstructive Pulmonary Disease Pulmonary Hypertension Drug: Udenafil Phase 3

Detailed Description:

Study design

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Udenafil on Exercise Capacity in Severe COPD Patients
Study Start Date : March 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Udenafil
Udenafil 50mg qd po
Drug: Udenafil
Udenafil 50mg qd po
Other Name: Zydena

Primary Outcome Measures :
  1. change of 6-minute walk distance [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. change of mean pulmonary artery pressure [ Time Frame: 8 weeks ]
    change of lung function, SGRQ score, Borg index, oxygen saturation, mean pulmonary artery pressure

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01364181

Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Dong-A PharmTech Co., Ltd.
Principal Investigator: Ho Il Yoon, M.D., Ph.D. Seoul National University Bundang Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ho Il Yoon, M.D. Ph.D., Seoul National University Hospital Identifier: NCT01364181     History of Changes
Other Study ID Numbers: Udenafil
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: June 20, 2011
Last Verified: May 2011

Keywords provided by Seoul National University Hospital:
Chronic obstructive pulmonary disease
pulmonary hypertension
Phosphodiesterase 5 inhibitors

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action