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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The Impact of Udenafil on Exercise Capacity in Severe COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364181
• Other study ID #: Udenafil
• Status: Completed
• Phase: Phase 3
• First received: May 31, 2011
• Last updated: June 17, 2011
• Start date: March 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Study design

• prospective, single arm, open-label study

• Udenafil 50mg qd po for 8 weeks

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Dyspnea
• Hypertension, Pulmonary
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Hypertension

Intervention

Drug:
• Udenafil
Udenafil 50mg qd po

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Dong-A PharmTech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of 6-minute walk distance		8 weeks	Yes
Secondary	change of mean pulmonary artery pressure	change of lung function, SGRQ score, Borg index, oxygen saturation, mean pulmonary artery pressure	8 weeks	Yes