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CompletedNCT01364181Updated Jun 20, 2011

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

A Phase 3 interventional study of Udenafil in Dyspnea, Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-06-20.

Sponsored by Seoul National University Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

Study design

  • prospective, single arm, open-label study
  • Udenafil 50mg qd po for 8 weeks
02

Conditions studied

  • Dyspnea
  • Chronic Obstructive Pulmonary Disease
  • Pulmonary Hypertension

Keywords

  • Udenafil
  • Chronic obstructive pulmonary disease
  • pulmonary hypertension
  • Phosphodiesterase 5 inhibitors
  • Exercise
  • Dyspnea
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 23 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Severe COPD who showed post-bronchodilator forced expiratory volume in 1 second (FEV1) less than 50% of predicted value

Exclusion criteria

Exclusion Criteria:

  • Acute exacerbation within 4 weeks of the study entry
  • Coronary heart disease
  • History of adverse event on PDE-5 inhibitors
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Udenafil

    Udenafil 50mg qd po

    Drug: Udenafil

Interventions

  • DrugUdenafil

    Udenafil 50mg qd po

    Also known as: Zydena

06

What researchers measure

Primary outcomes

  1. change of 6-minute walk distance

    Time frame: 8 weeks

Secondary outcomes

  1. change of mean pulmonary artery pressure

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

    Time frame: 8 weeks

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam, Gyeonggi-do 463-707, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 22946546 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01364181
Lead sponsor
Seoul National University Hospital
Collaborators
Dong-A PharmTech Co., Ltd.
First posted
Jun 2, 2011
Start date
Mar 2010
Primary completion
Mar 2011
Completion
May 2011
Last update
Jun 20, 2011

Study contacts

Ho Il Yoon, M.D., Ph.D.
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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