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This study aims at evaluating efficacy and safety of Symbicort® Turbuhaler® in Chinese COPD patients as defined by GOLD treatment guidelines in order to obtain an approval for indication of COPD from Chinese State Food and Drug Administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Bricasol® |
|
| 2 | Experimental | Bricasol® + Pulmicort® |
|
| 3 | Experimental | Bricasol® + Symbicort® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide/formoterol (Symbicort) | Drug | inhalation therapy |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-study medication FEV1 | 1 hour after medication |
| Measure | Description | Time Frame |
|---|---|---|
| FVC | Pre dose and 1 hour post dose | |
| FEV1 | Pre-dose and 15 minutes post dose | |
| SGRQ symptom scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Symbicort Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Beijing | Beijing Municipality | China | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22046961 | Derived | Zhong N, Zheng J, Wen F, Yang L, Chen P, Xiu Q, Yao W, Sun T, Zhao Z, Shen H, Shi Y, Lin J, Li Q. Efficacy and safety of budesonide/formoterol via a dry powder inhaler in Chinese patients with chronic obstructive pulmonary disease. Curr Med Res Opin. 2012 Feb;28(2):257-65. doi: 10.1185/03007995.2011.636420. Epub 2012 Jan 20. |
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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 |
|---|---|
| D019819 | Budesonide |
| D000068759 | Formoterol Fumarate |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D013726 | Terbutaline |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| budesonide (Pulmicort) | Drug | inhalation |
|
|
| terbutaline sulfate (Bricasol) | Drug | inhalation therapy |
|
|
| COPD symptom scores |
| morning and evening PEF | Assessed daily |
| reliever medication use |
| AE |
| lab measures |
| ECG |
| physician examination |
| vital signs |
| Guangzhou |
| Guangdong |
| China |
| Research Site | Nanjing | Jiangsu | China |
| Research Site | Shenyang | Liaoling | China |
| Research Site | Shanghai | Shanghai Municipality | China |
| Research Site | Xi’an | Shanxi | China |
| Research Site | Chengdu | Sichuan | China |
| Research Site | Hangzhou | Zhejiang | China |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |