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| ID | Type | Description | Link |
|---|---|---|---|
| SCO113162 | Other Grant/Funding Number | GlaxoSmithKline |
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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
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To determine the efficacy and safety of Salmeterol/Fluticasone Propionate 50/500ug BID vs Ipratropium/Albuterol 36/206ug QID in Chinese patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD).
This is a 12-week, multicentre,randomized,open-label,active-controlled, paralleled-group study.
Chinese patients aged ≥40 years with moderate-to-severe COPD are eligible for this study.
Eligible patients will be randomized (1:1) to the following 2 treatments for 12 weeks.
A Follow-up visit will be conducted 2 weeks after completion of treatment/early withdrawal to assess for any adverse effects after discontinuing study treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipratropium/Albuterol | Active Comparator | Ipratropium/Albuterol 36/206ug QID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salmeterol/Fluticasone Propionate | Drug | Salmeterol/Fluticasone 50/500ug twice daily Duration:12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| pre-broncholidator FEV1 | Change from Baseline in pre-broncholidator FEV1 at 12 weeks | at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| post-broncholidator FEV1 | Change from Baseline in post-broncholidator FEV1 at 12 weeks | at 12 weeks |
| Morning PEF, inspiration capacity (IC) and Residual Volume (RV) | Change from Baseline in morning PEF, inspiration capacity (IC) and Residual Volume (RV)at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yutong Y GU, Doctor | Contact | 8621-64041990 | 2445 | gu.yutong@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Chunxue C BAI, Doctor | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Anhui Medical College | Recruiting | Hefei | Anhui | 230022 | China |
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| Guangzhou First People's Hospital |
| OTHER |
| Peking Union Medical College Hospital | OTHER |
| Beijing Chao Yang Hospital | OTHER |
| Peking University Third Hospital | OTHER |
| Liaoning Cancer Hospital & Institute | OTHER |
| West China Hospital | OTHER |
| Xinqiao Hospital of Chongqing | OTHER |
| Qingdao University | OTHER |
| Armed Police Medical college Affiliated Hospital | UNKNOWN |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| Henan Provincial People's Hospital | OTHER |
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| at 12 weeks |
| Overall daytime symptom score, reliever medication use,SGRQ and BODY index | Change from Baseline in overall daytime symptom score, reliever medication use,SGRQ and BODY index at 12 weeks | at 12 weeks |
| Percent of symptom-free nights, sleep symptoms, nighttime awakenings due to respiratory symptoms | Change from Baseline in percent of symptom-free nights, sleep symptoms, nighttime awakenings due to respiratory symptoms at 12 weeks | at 12 weeks |
| Biomarkers: serum Clara cell 16 (CC-16) protein and serum surfactant protein D (SPD) | Change from Baseline in biomarkers: serum Clara cell 16 (CC-16) protein and serum surfactant protein D (SPD) at 12 weeks | at 12 weeks |
| participants with adverse events and COPD exacerbations | Change from Baseline in number of participants with adverse events and COPD exacerbations at 12 weeks | at 12 weeks |
| Beijing Chaoyang Hospital | Recruiting | Beijing | Beijing Municipality | 100020 | China |
|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
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| Gguang Zhou Institute of Respiratory Disease | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| Henan Province Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
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| Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | 210004 | China |
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| Wuxi People's Hospital, | Recruiting | Wuxi | Jiangsu | 214002 | China |
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| Shenyang Military General Hospital | Recruiting | Shenyang | Liaoning | 110016 | China |
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| Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| West China Hospital of Sichuan | Recruiting | Chengdu | Sichuan | 610041 | China |
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| Chongqing Xinqiao Hospital | Recruiting | Chongqing | Sichuan | 430007 | China |
|
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| D000068600 | Albuterol, Ipratropium Drug Combination |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D009241 | Ipratropium |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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