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

This study has been completed.
Dong-A PharmTech Co., Ltd.
Information provided by:
Seoul National University Hospital Identifier:
First received: May 31, 2011
Last updated: June 17, 2011
Last verified: May 2011

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
Pulmonary Hypertension
Drug: Udenafil
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Udenafil on Exercise Capacity in Severe COPD Patients

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • change of 6-minute walk distance [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • change of mean pulmonary artery pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    change of lung function, SGRQ score, Borg index, oxygen saturation, mean pulmonary artery pressure

Enrollment: 23
Study Start Date: March 2010
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Udenafil
Udenafil 50mg qd po
Drug: Udenafil
Udenafil 50mg qd po
Other Name: Zydena

Detailed Description:

Study design

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: 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
  More Information

No publications provided by Seoul National University Hospital

Additional 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
Study First Received: May 31, 2011
Last Updated: June 17, 2011
Health Authority: South Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Hypertension, Pulmonary
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions processed this record on April 17, 2014