Chronic Obstructive Pulmonary Disease (COPD)Phase 2BTCOPDNCT02093195
Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients
A Phase 2 study testing Bosentan and Symbicort turbuhaler in people with Chronic Obstructive Pulmonary Disease (COPD), run by Air Force Military Medical University, China at 5 sites in China.
Trial summary
Present treatment for chronic obstructive pulmonary disease (COPD) has a certain role in reducing COPD exacerbation and hospitalization, improving the life quality, and postponing the lung function decline. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Bosentan and Symbicort turbuhaler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesChina
- Study dates
- Dec 2013to Dec 2015
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75
- Gold Ⅲ or Ⅳ stable COPD
- Pulmonary hypertension detected by echocardiography
Who cannot join
- Acute exacerbation of chronic obstructive pulmonary disease
- Untreated obstructive sleep apnea
- Restrictive (total lung capacity<60% predicted) lung disease
- Portal hypertension
- Chronic liver disease
- Transaminase increased to normal line more than 3 times; total bilirubin increased 2 times more than the upper limit of the normal value
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- Left-sided or unrepaired congenital heart disease
- Patients with other serious heart diseases
- Patients with 1, 2, 4 and 5 categories of pulmonary hypertension
- Unable to complete the 6 minutes walk test
- Patients receiving other endothelin receptor antagonists
- No cooperation to complete
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
The second affiliated hospital of xi'an jiaotong university
Xi'an, Shaanxi, 710004
YUAN LIU, MD, liuyuan@xjtu.edu.cn
YUAN LIU, MD
- Recruiting
The department of pulmonary and critical care medicine, Xijing hospital
Xi'an, Shaanxi, 710032
Xinpeng Han, MD, +86-29-84771135, hxp0728@163.com
Xinpeng Han, MD
- Recruiting
The department of pulmonary and critical care medicine, Tangdou hospital
Xi'an, Shaanxi, 710038
yandong nan, MD, 13709205538@163.com
YANDONG NAN, MD
- Recruiting
The first affiliated hospital of xi'an jiaotong university
Xi'an, Shaanxi, 710064
ting liu, MD, 18991938962
TING LIU, MD
- Recruiting
Shaanxi Provincial People'S Hospital
Xi'an, Shaanxi, 710068
LINGBIN XU, MD, 18542705@qq.com
LINGBIN XU, MD
About this study
Official title: Phase Ⅱ Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients
Present treatment for chronic obstructive pulmonary disease (COPD) has a certain role in reducing COPD exacerbation and hospitalization, improving the life quality, and postponing the lung function decline. But for some patients with severe COPD, current treatment only partially alleviates the symptoms and has little role in the lung function decline. In this randomized, multicenter study, the investigators evaluate the safety and efficacy of bosentan in the treatment of grade Ⅲ or Ⅳ COPD patients with pulmonary hypertension detected by echocardiography. The primary endpoint is the frequency of COPD exacerbation, and the secondary endpoint includes changes of lung function, 6-min-walk distance (6-MWD), SGRQ score and mMRC/CAT score.
- Being tested
- Bosentan, Symbicort turbuhaler
- Keywords
- Treatment, COPD, bosentan
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosentanDrug
Symbicort turbuhalerDrug
| Study group | Role | What they receive |
|---|---|---|
| Bosentan | Experimental | Bosentan,125mg,po,bid combined with inhaled Symbicort turbuhaler, 320/9μg, bid. Receives: Drug: Bosentan; Drug: Symbicort turbuhaler |
| Control | Active comparator | Inhaled Symbicort turbuhaler, 320/9μg, bid. Receives: Drug: Symbicort turbuhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of COPD Exacerbation
Measured: 12 months
Secondary outcomes (4)
6-min-walk distance (6-MWD)
Measured: 12 months
Lung Function
Measured: 12 months
mMRC/CAT score
Measured: 12 months
SGRQ score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengqing Li, Air Force Military Medical University, China
- Investigators
- Shengqing Li, MD, PhD, Principal investigator, The department of pulmonary and critical care medicine, Xijing hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093195
- Sponsor's protocol ID
- BTCOPD-2014226
- Acronym
- BTCOPD
- Status last verified
- Mar 2014
- First submitted
- 18 Mar 2014
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT02093195
- Acronym / sponsor ID
- BTCOPD / BTCOPD-2014226
- Keywords
- Treatment, COPD, bosentan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 20 Mar 2014 (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.
Present treatment for chronic obstructive pulmonary disease (COPD) has a certain role in reducing COPD exacerbation and hospitalization, improving the life quality, and postponing the lung function decline. But for some patients with severe COPD, current treatment only partially alleviates the symptoms and has little role in the lung function decline. In this randomized, multicenter study, the investigators evaluate the safety and efficacy of bosentan in the treatment of grade Ⅲ or Ⅳ COPD patients with pulmonary hypertension detected by echocardiography. The primary endpoint is the frequency of COPD exacerbation, and the secondary endpoint includes changes of lung function, 6-min-walk distance (6-MWD), SGRQ score and mMRC/CAT score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bosentan | Experimental | Drug: Bosentan, Drug: Symbicort turbuhalerBosentan,125mg,po,bid combined with inhaled Symbicort turbuhaler, 320/9μg, bid. |
| Control | Active comparator | Drug: Symbicort turbuhalerInhaled Symbicort turbuhaler, 320/9μg, bid. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 75
- Gold Ⅲ or Ⅳ stable COPD
- Pulmonary hypertension detected by echocardiography
Key exclusion criteria (12 listed)
- Acute exacerbation of chronic obstructive pulmonary disease
- Untreated obstructive sleep apnea
- Restrictive (total lung capacity<60% predicted) lung disease
- Portal hypertension
- Chronic liver disease
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 |
|---|---|---|
| Bosentan | Drug | Bosentan |
| Symbicort turbuhaler | Drug | Bosentan, Control |
Primary outcome
Frequency of COPD Exacerbation
Time frame: 12 months
4 secondary outcomes
6-min-walk distance (6-MWD)
Time frame: 12 months
Lung Function
Time frame: 12 months
mMRC/CAT score
Time frame: 12 months
SGRQ score
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
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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.
Shengqing Li, MD, PhD principal investigator
The department of pulmonary and critical care medicine, Xijing hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bosentan and Symbicort turbuhaler in people with Chronic Obstructive Pulmonary Disease (COPD), run by Air Force Military Medical University, China at 5 sites 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 12 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 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Shengqing Li, MD, PhD (+86-29-84771132, shengqingli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of COPD Exacerbation (time frame: 12 months). 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 20 Mar 2014.