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

This study has been completed.
Sponsor:
Collaborator:
Dong-A PharmTech Co., Ltd.
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01364181
First received: May 31, 2011
Last updated: June 17, 2011
Last verified: May 2011

May 31, 2011
June 17, 2011
March 2010
March 2011   (final data collection date for primary outcome measure)
change of 6-minute walk distance [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01364181 on ClinicalTrials.gov Archive Site
change of mean pulmonary artery pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
change of lung function, SGRQ score, Borg index, oxygen saturation, mean pulmonary artery pressure
Same as current
Not Provided
Not Provided
 
The Impact of Udenafil on Exercise Capacity in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
The Impact of Udenafil on Exercise Capacity in Severe 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.

Study design

  • prospective, single arm, open-label study
  • Udenafil 50mg qd po for 8 weeks
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Dyspnea
  • Chronic Obstructive Pulmonary Disease
  • Pulmonary Hypertension
Drug: Udenafil
Udenafil 50mg qd po
Other Name: Zydena
Experimental: Udenafil
Udenafil 50mg qd po
Intervention: Drug: Udenafil
Park JS, Lim HJ, Cho YJ, Lee JH, Yoon HI, Lee CT. Udenafil improves exercise capacity in patients with chronic obstructive pulmonary disease: a prospective study. COPD. 2012 Aug;9(5):499-504. doi: 10.3109/15412555.2012.694922. Epub 2012 Sep 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
May 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01364181
Udenafil
Yes
Ho Il Yoon, M.D. Ph.D., Seoul National University Hospital
Seoul National University Hospital
Dong-A PharmTech Co., Ltd.
Principal Investigator: Ho Il Yoon, M.D., Ph.D. Seoul National University Bundang Hospital
Seoul National University Hospital
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP