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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 â…¢ or â…£ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bosentan | Experimental | Bosentan,125mg,po,bid combined with inhaled Symbicort turbuhaler, 320/9μg, bid. |
|
| Control | Active Comparator | Inhaled Symbicort turbuhaler, 320/9μg, bid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosentan | Drug |
| ||
| Symbicort turbuhaler |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of COPD Exacerbation | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6-min-walk distance (6-MWD) | 12 months | |
| Lung Function | 12 months | |
| mMRC/CAT score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengqing Li, MD, PhD | Contact | +86-29-84771132 | shengqingli@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shengqing Li, MD, PhD | The department of pulmonary and critical care medicine, Xijing hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second affiliated hospital of xi'an jiaotong university | Recruiting | Xi'an | Shaanxi | 710004 | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000077300 | Bosentan |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| 12 months |
| SGRQ score | 12 months |
| The department of pulmonary and critical care medicine, Xijing hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
|
| The department of pulmonary and critical care medicine, Tangdou hospital | Recruiting | Xi'an | Shaanxi | 710038 | China |
|
| The first affiliated hospital of xi'an jiaotong university | Recruiting | Xi'an | Shaanxi | 710064 | China |
|
| Shaanxi Provincial People'S Hospital | Recruiting | Xi'an | Shaanxi | 710068 | China |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D019819 | Budesonide |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |