DyspneaPhase 3NCT01364181
The Impact of Udenafil on Exercise Capacity in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 3 study testing Udenafil in people with Dyspnea and Chronic Obstructive Pulmonary Disease, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Dyspnea, Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension
- What is being tested?
- Udenafil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2010to May 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe COPD who showed post-bronchodilator forced expiratory volume in 1 second (FEV1) less than 50% of predicted value
Who cannot join
- Acute exacerbation within 4 weeks of the study entry
- Coronary heart disease
- History of adverse event on PDE-5 inhibitors
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: 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.
Read the detailed description
Study design
- prospective, single arm, open-label study
- Udenafil 50mg qd po for 8 weeks
- Being tested
- Udenafil
- Keywords
- Udenafil, Chronic obstructive pulmonary disease, pulmonary hypertension, Phosphodiesterase 5 inhibitors, Exercise, Dyspnea
- Medical subject headings
- Dyspnea, Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UdenafilDrug
Also called Zydena
Udenafil 50mg qd po
| Study group | Role | What they receive |
|---|---|---|
| Udenafil | Experimental | Udenafil 50mg qd po Receives: Drug: Udenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of 6-minute walk distance
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A PharmTech Co., Ltd.
- Investigators
- Ho Il Yoon, M.D., Ph.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364181
- Sponsor's protocol ID
- Udenafil
- Status last verified
- May 2011
- First submitted
- 31 May 2011
- Last updated
- 20 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Udenafil on Exercise Capacity in Severe COPD Patients
- ClinicalTrials.gov ID
- NCT01364181
- Acronym / sponsor ID
- Udenafil
- Keywords
- Udenafil, Chronic obstructive pulmonary disease, pulmonary hypertension, Phosphodiesterase 5 inhibitors, Exercise, Dyspnea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Dong-A PharmTech Co., Ltd.
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Udenafil | Experimental | Drug: UdenafilUdenafil 50mg qd po |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Severe COPD who showed post-bronchodilator forced expiratory volume in 1 second (FEV1) less than 50% of predicted value
Key exclusion criteria (3 listed)
- Acute exacerbation within 4 weeks of the study entry
- Coronary heart disease
- History of adverse event on PDE-5 inhibitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UdenafilAlso: ZydenaUdenafil 50mg qd po | Drug | Udenafil |
Primary outcome
change of 6-minute walk distance
Time frame: 8 weeks
1 secondary outcome
change of mean pulmonary artery pressure
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2011.
- Derived from this study: PubMed 22946546Park 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho Il Yoon, M.D., Ph.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Udenafil in people with Dyspnea and Chronic Obstructive Pulmonary Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of 6-minute walk distance (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01364181, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2011.