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

Phase 3

Completed

• Conditions: Dyspnea; Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension
• Interventions: Drug: Udenafil

• Registration Number: NCT01364181
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Study design

* prospective, single arm, open-label study

* Udenafil 50mg qd po for 8 weeks

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-03
• Status Verified: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-02
• Last Update Submitted: 2011-06-17
• Last Update Posted: 2011-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Udenafil	Udenafil	Udenafil 50mg qd po

Primary Outcome Measures

Name	Time	Method
change of 6-minute walk distance	8 weeks

Secondary Outcome Measures

Name	Time	Method
change of mean pulmonary artery pressure	8 weeks	change of lung function, SGRQ score, Borg index, oxygen saturation, mean pulmonary artery pressure

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of