Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients
NCT ID: NCT02093195
Last Updated: 2014-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bosentan
Bosentan,125mg,po,bid combined with inhaled Symbicort turbuhaler, 320/9μg, bid.
Bosentan
Symbicort turbuhaler
Control
Inhaled Symbicort turbuhaler, 320/9μg, bid.
Symbicort turbuhaler
Interventions
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Bosentan
Symbicort turbuhaler
Eligibility Criteria
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Inclusion Criteria
* Gold Ⅲ or Ⅳ stable COPD
* Pulmonary hypertension detected by echocardiography
Exclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Air Force Military Medical University, China
OTHER
Responsible Party
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Shengqing Li
Associate Chief Physician, Associate Professor
Principal Investigators
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Shengqing Li, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The department of pulmonary and critical care medicine, Xijing hospital
Locations
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The second affiliated hospital of xi'an jiaotong university
Xi'an, Shaanxi, China
The department of pulmonary and critical care medicine, Xijing hospital
Xi'an, Shaanxi, China
The department of pulmonary and critical care medicine, Tangdou hospital
Xi'an, Shaanxi, China
The first affiliated hospital of xi'an jiaotong university
Xi'an, Shaanxi, China
Shaanxi Provincial People'S Hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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ting liu, MD
Role: primary
Other Identifiers
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BTCOPD-2014226
Identifier Type: -
Identifier Source: org_study_id
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