Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients (BTCOPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Bosentan
Symbicort turbuhaler
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Treatment, COPD, bosentan
Eligibility Criteria
Inclusion Criteria:
- Aged 18 to 75
- Gold Ⅲ or Ⅳ stable COPD
- Pulmonary hypertension detected by echocardiography
Exclusion Criteria:
- 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
- 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
Sites / Locations
- The second affiliated hospital of xi'an jiaotong universityRecruiting
- The department of pulmonary and critical care medicine, Xijing hospitalRecruiting
- Shaanxi Provincial People'S HospitalRecruiting
- The department of pulmonary and critical care medicine, Tangdou hospitalRecruiting
- The first affiliated hospital of xi'an jiaotong universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bosentan
Control
Arm Description
Bosentan,125mg,po,bid combined with inhaled Symbicort turbuhaler, 320/9μg, bid.
Inhaled Symbicort turbuhaler, 320/9μg, bid.
Outcomes
Primary Outcome Measures
Frequency of COPD Exacerbation
Secondary Outcome Measures
6-min-walk distance (6-MWD)
Lung Function
mMRC/CAT score
SGRQ score
Full Information
NCT ID
NCT02093195
First Posted
March 18, 2014
Last Updated
March 18, 2014
Sponsor
Air Force Military Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT02093195
Brief Title
Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients
Acronym
BTCOPD
Official Title
Phase Ⅱ Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Treatment, COPD, bosentan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bosentan
Arm Type
Experimental
Arm Description
Bosentan,125mg,po,bid combined with inhaled Symbicort turbuhaler, 320/9μg, bid.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Inhaled Symbicort turbuhaler, 320/9μg, bid.
Intervention Type
Drug
Intervention Name(s)
Bosentan
Intervention Type
Drug
Intervention Name(s)
Symbicort turbuhaler
Primary Outcome Measure Information:
Title
Frequency of COPD Exacerbation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
6-min-walk distance (6-MWD)
Time Frame
12 months
Title
Lung Function
Time Frame
12 months
Title
mMRC/CAT score
Time Frame
12 months
Title
SGRQ score
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 to 75
Gold Ⅲ or Ⅳ stable COPD
Pulmonary hypertension detected by echocardiography
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengqing Li, MD, PhD
Phone
+86-29-84771132
Email
shengqingli@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengqing Li, MD, PhD
Organizational Affiliation
The department of pulmonary and critical care medicine, Xijing hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The second affiliated hospital of xi'an jiaotong university
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YUAN LIU, MD
Email
liuyuan@xjtu.edu.cn
First Name & Middle Initial & Last Name & Degree
YUAN LIU, MD
Facility Name
The department of pulmonary and critical care medicine, Xijing hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinpeng Han, MD
Phone
+86-29-84771135
Email
hxp0728@163.com
First Name & Middle Initial & Last Name & Degree
Xinpeng Han, MD
Facility Name
Shaanxi Provincial People'S Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710068
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LINGBIN XU, MD
Email
18542705@qq.com
First Name & Middle Initial & Last Name & Degree
LINGBIN XU, MD
Facility Name
The department of pulmonary and critical care medicine, Tangdou hospital
City
Xian
State/Province
Shaanxi
ZIP/Postal Code
710038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yandong nan, MD
Email
13709205538@163.com
First Name & Middle Initial & Last Name & Degree
YANDONG NAN, MD
Facility Name
The first affiliated hospital of xi'an jiaotong university
City
Xian
State/Province
Shaanxi
ZIP/Postal Code
710064
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ting liu, MD
Phone
18991938962
First Name & Middle Initial & Last Name & Degree
TING LIU, MD
12. IPD Sharing Statement
Learn more about this trial
Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients
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