Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients

Study Overview
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Brief Summary
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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.

Official Title
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Phase Ⅱ Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Bosentan
* Drug: Symbicort turbuhaler


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bosentan<br>Bosentan,125mg,po,bid combined with inhaled Symbicort turbuhaler, 320/9μg, bid. | Drug: Bosentan<br> <br> Drug: Symbicort turbuhaler<br> <br> |
| Active Comparator: Control<br>Inhaled Symbicort turbuhaler, 320/9μg, bid. | Drug: Symbicort turbuhaler<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of COPD Exacerbation |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-min-walk distance (6-MWD) |  | 12 months | 
| Lung Function |  | 12 months | 
| mMRC/CAT score |  | 12 months | 
| SGRQ score |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment, COPD, bosentan