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

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Dyspnea; Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension

Treatments: Drug: Udenafil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01364181

Udenafil

Details and patient eligibility

About

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.

Full description

Study design

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

Enrollment: 23 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Udenafil

Experimental group

Description:

Udenafil 50mg qd po

Treatment:

Drug: Udenafil