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

Seoul National University Hospital23 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dyspnea Chronic Obstructive Pulmonary Disease Pulmonary Hypertension

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

change of 6-minute walk distance

Time frame: 8 weeks

Secondary Outcomes

change of mean pulmonary artery pressure

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