Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Dong-A PharmTech Co., Ltd.
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01364181
First received: May 31, 2011
Last updated: June 17, 2011
Last verified: May 2011
  Purpose

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
Dyspnea
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
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364181

Locations
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.
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ho Il Yoon, M.D. Ph.D., Seoul National University Hospital
ClinicalTrials.gov 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:
Udenafil
Chronic obstructive pulmonary disease
pulmonary hypertension
Phosphodiesterase 5 inhibitors
Exercise
Dyspnea

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

ClinicalTrials.gov processed this record on November 19, 2014