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Completed

NCT Number: NCT01364181

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

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.

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Key information

Conditions

Dyspnea Behavior Cardiovascular Diseases Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Hypertension Hypertension, Pulmonary Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Pulmonary Hypertension Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

Study design

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Udenafil

Drug

Udenafil 50mg qd po

Other names: Zydena

Primary outcomes

  1. change of 6-minute walk distance

    Time frame: 8 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Dong-A PharmTech Co., Ltd.

Registry information

Official study title

The Impact of Udenafil on Exercise Capacity in Severe COPD Patients

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 2, 2011
Registry last updated
Jun 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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