Chronic Obstructive Pulmonary Disease, Dyspnea, Pulmonary Hypertension
Conditions
Keywords
Udenafil, Chronic obstructive pulmonary disease, pulmonary hypertension, Phosphodiesterase 5 inhibitors, Exercise, Dyspnea
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
Interventions
DRUGUdenafil
Udenafil 50mg qd po
Sponsors
Dong-A PharmTech Co., Ltd.
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
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
* Acute exacerbation within 4 weeks of the study entry * Coronary heart disease * History of adverse event on PDE-5 inhibitors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of 6-minute walk distance | 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of mean pulmonary artery pressure | 8 weeks | change of lung function, SGRQ score, Borg index, oxygen saturation, mean pulmonary artery pressure |
Countries
South Korea
Outcome results
None listed