COPDNCT03185364
The Safety and Efficiency of Sildenafil in the Treatment of Severe Post-capillary Pulmonary Hypertension Caused by COPD
A study testing Sildenafil Citrate in people with COPD and Pulmonary Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
Over half of chronic obstructive pulmonary disease (COPD) patients develop pulmonary hypertension. The current therapy focuses only on the basic disease and there are a lot of controversies about the use of PAH target therapy in group 3 pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD, Pulmonary Hypertension
- What is being tested?
- Sildenafil Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2017to 31 Dec 2020
- Phase
- Interventional
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable for over 1 month
- mean pulmonary artery pressure ≥35mmHg, pulmonary wedge pressure≤ 15mmHg
- never received target therapy before
Who cannot join
- Patients with other serious respiratory diseases
- Patients with pulmonary hypertension other than group 3
- Patients with right heart hypertrophy or dysfunction not caused by chronic obstructive pulmonary diseases
- Patients with limited life expectancy
- Patients with history of tracheal intubation or stoke, acute coronary syndrome in 6 months
- Psychopath or addict
Show all 9Show fewer
- Nonstable patients with type Ⅰor Ⅱ respiratory failure
- Patients with contraindication for sildenafil
- Patients in pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Guohua Hu, MD, 13517277794, guohuazhen@hotmail.com
13517277794, guohuazhen@hotmail.com
About this study
Over half of chronic obstructive pulmonary disease (COPD) patients develop pulmonary hypertension. The current therapy focuses only on the basic disease and there are a lot of controversies about the use of PAH target therapy in group 3 pulmonary hypertension. Our study is to explore whether sildenafil, a pulmonary arterial hypertension (PAH) target drug, could be efficient and safe in improving symptoms and survival of severe pulmonary hypertension caused by COPD.
- Conditions
- COPD, Pulmonary Hypertension
- Being tested
- Sildenafil Citrate, Placebo Oral Tablet
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil CitrateDrug
sildenafil treatment for 12 weeks, monitoring blood pressure and other adverse events
Placebo Oral TabletDrug
placebos treatment for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Sildenafil Citrate, 20mg, tid for 12 weeks Receives: Drug: Sildenafil Citrate |
| Control group | Placebo comparator | placebo oral tablet, 12 weeks Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary artery pressure
pressure in mmHg
Measured: 12 weeks
pulmonary vascular resistance
woods
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start15 Jun 2017 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 23 patients use placebo and 23 patients use sidenafil for 12 weeks' treatment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185364
- Sponsor's protocol ID
- 2016YFC1304401B
- Status last verified
- Jun 2017
- First submitted
- 11 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficiency of Sildenafil in the Treatment of Severe Post-capillary Pulmonary Hypertension Caused by COPD
- ClinicalTrials.gov ID
- NCT03185364
- Acronym / sponsor ID
- 2016YFC1304401B
- Conditions
- COPD, Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 15 Jun 2017 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Jun 2017 (actual)
- 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.
Over half of chronic obstructive pulmonary disease (COPD) patients develop pulmonary hypertension. The current therapy focuses only on the basic disease and there are a lot of controversies about the use of PAH target therapy in group 3 pulmonary hypertension. Our study is to explore whether sildenafil, a pulmonary arterial hypertension (PAH) target drug, could be efficient and safe in improving symptoms and survival of severe pulmonary hypertension caused by COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 23 patients use placebo and 23 patients use sidenafil for 12 weeks' treatment
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Drug: Sildenafil CitrateSildenafil Citrate, 20mg, tid for 12 weeks |
| Control group | Placebo comparator | Drug: Placebo Oral Tabletplacebo oral tablet, 12 weeks |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable for over 1 month
- mean pulmonary artery pressure ≥35mmHg, pulmonary wedge pressure≤ 15mmHg
- never received target therapy before
Key exclusion criteria (9 listed)
- Patients with other serious respiratory diseases
- Patients with pulmonary hypertension other than group 3
- Patients with right heart hypertrophy or dysfunction not caused by chronic obstructive pulmonary diseases
- Patients with limited life expectancy
- Patients with history of tracheal intubation or stoke, acute coronary syndrome in 6 months
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 |
|---|---|---|
| Sildenafil Citratesildenafil treatment for 12 weeks, monitoring blood pressure and other adverse events | Drug | Interventional group |
| Placebo Oral Tabletplacebos treatment for 12 weeks | Drug | Control group |
Primary outcome
pulmonary artery pressure
Time frame: 12 weeks
pressure in mmHg
pulmonary vascular resistance
Time frame: 12 weeks
woods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sildenafil Citrate in people with COPD and Pulmonary Hypertension, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Jun 2017. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulmonary artery pressure (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2017.