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To evaluate the efficacy and safety of TQC2731 injection in patients with moderate to severe chronic obstructive pulmonary disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQC2731 injection | Experimental | TQC2731 injection, 28days as a treatment cycle. |
|
| TQC2731 Placebo | Placebo Comparator | TQC2731 Placebo, 28days as a treatment cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQC2731 injection | Drug | TQC2731 injection is a monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annual rate of acute COPD exacerbation | Annualized rate of moderate or severe COPD exacerbations over the 24-week treatment period compared to placebo | Baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pre-bronchodilator forced expiratory volume (FEV1) | Change in pre-bronchodilator FEV1 from baseline to week 24 compared to placebo. | Baseline to week 24 |
| Annual rate of acute COPD exacerbation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First People's Hospital of Chuzhou | Chuzhou | Anhui | 239001 | China | ||
| The second hospital of ANHUI medical university |
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| TQC2731 Placebo | Drug | TQC2731 Placebo without drug substance. |
|
Annualized rate of moderate COPD exacerbations over the 52-week treatment period compared to placebo.
| Baseline to week 52 |
| Improvement in St. George's Respiratory Questionnaire (SGRQ) | Proportion of patients with SGRQ improvement ≥4 points at Week 52 | Baseline to week 52 |
| Change in SGRQ | Change from baseline to Week 52 in SGRQ total score compared to placebo | Baseline to week 52 |
| Change in pre-bronchodilator FEV1 | Change in pre-bronchodilator FEV1 from baseline to week 52 compared to placebo. | Baseline to week 52 |
| Annual rate of acute COPD exacerbation | Annualized rate of severe COPD exacerbations over the 52-week treatment period compared to placebo. | Baseline to week 52 |
| Change in post-bronchodilator FEV1 | Change in post-bronchodilator FEV1 from baseline to week 24 and 52 compared to placebo. | Baseline to week 24 and 52 |
| Change in EXACT | Change from baseline to Week 52 in EXACT total score compared to placebo. | Baseline to week 52 |
| Adverse Events (AE) and Serious Adverse Events (SAE) | The incidence and severity of AE and SAE, as well as abnormal laboratory examination index. | Baseline to 64 weeks |
| Anti-drug antibodies (ADA) | Incidence of ADA. | Baseline through week 52 |
| Immunoglobulin E (IgE) | Changes in IgE levels in peripheral blood. | Baseline to 52 weeks |
| Fractional exhaled nitric oxide (FeNO) | Changes in FeNO. | Baseline to 52 weeks |
| Hefei |
| Anhui |
| 230601 |
| China |
| Huainan Dongfang Hospital Group General Hospital | Huainan | Anhui | 232033 | China |
| Capital Medical University Beijing Chaoyang Hospital | Beijing | Beijing Municipality | 100020 | China |
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
| The First Hospital of Lanzhou University | Lanzhou | Gansu | 730000 | China |
| Shunde Hospital Of Southern Medical University | Foshan | Guangdong | 528308 | China |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510120 | China |
| Jiangmen Central Hospital | Jiangmen | Guangdong | 529000 | China |
| Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital | Qingyuan | Guangdong | 511699 | China |
| Zhongshan City People's Hospital | Zhongshan | Guangdong | 528403 | China |
| Nanxishan Hospital of Guangxi Zhuang Autonomous | Guilin | Guangxi | 541002 | China |
| The First People' Hospital Of YuLin | Yulin | Guangxi | 537000 | China |
| Zunyi Medical University Affiliated Hospital | Zunyi | Guizhou | 563000 | China |
| Cangzhou Central Hospital | Cangzhou | Hebei | 611011 | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
| Jiaozuo Second People's Hospital | Jiaozuo | Henan | 454150 | China |
| The First Affiliated Hospital of Henan University of Science & Technology | Luoyang | Henan | 471003 | China |
| Puyang Oilfield General Hospital | Puyang | Henan | 457001 | China |
| Henan Chest Hospital | Zhengzhou | Henan | 450000 | China |
| Jianghan University Affiliated Hospital (Wuhan Sixth Hospital) | Wuhan | Hubei | 430014 | China |
| Wuhan Central Hospital | Wuhan | Hubei | 430014 | China |
| Yichang Central People's Hospital | Yichang | Hubei | 443003 | China |
| Changsha First Hospital | Changsha | Hunan | 410005 | China |
| Xiangya Hospital of Central South University | Changsha | Hunan | 410008 | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
| Xiangtan County People's Hospital | Xiangtan | Hunan | 411228 | China |
| Xiangya Hospital Zhuzhou Central South University | Zhuzhou | Hunan | 412007 | China |
| Inner Mongolia Autonomous Region People's Hospital | Hohhot | Inner Mongolia | 010000 | China |
| The Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | 10000 | China |
| Jiangyin Hospital of Traditional Chinese Medicine | Jiangyin | Jiangsu | 214400 | China |
| The Fifth People's Hospital of Wuxi | Wuxi | Jiangsu | 214001 | China |
| Yixing People'S Hospital | Wuxi | Jiangsu | 214200 | China |
| XuZhou Central Hospital | Xuzhou | Jiangsu | 221000 | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | 212050 | China |
| Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | 330006 | China |
| Xinyu People'S Hospital | Xinyu | Jiangxi | 338000 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| General Hospital of Anshan Iron and Steel Group Corporation | Anshan | Liaoning | 114000 | China |
| Benxi Central Hospital | Benxi | Liaoning | 117000 | China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110004 | China |
| Heze Municipal Hospital | Heze | Shandong | 274000 | China |
| Linyi People's Hospital | Linyi | Shandong | 276005 | China |
| Qingdao Municipal Hospital | Qingdao | Shandong | 266011 | China |
| Weifang NO.2 People' Hospital | Weifang | Shandong | 261041 | China |
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
| Shanghai JiaoTong University of medicine Ruijin Hospital | Shanghai | Shanghai Municipality | 20025 | China |
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| Affiliated Hospital Of ChengDu University | Chengdu | Sichuan | 610081 | China |
| Guangyuan Central Hospital | Guangyuan | Sichuan | 628017 | China |
| Leshan People's Hospital | Leshan | Sichuan | 614099 | China |
| Meishan People's Hospital | Meishan | Sichuan | 620000 | China |
| Suining Central Hospital | Suining | Sichuan | 629000 | China |
| General Hospital of Tianjin Medical University | Tianjin | Tianjin Municipality | 300070 | China |
| The Fourth Central Hospital of Tianjin | Tianjin | Tianjin Municipality | 300140 | China |
| The First Affiliated Hospital of Shihezi University | Shihezi | Xinjiang | 832000 | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 831400 | China |
| Jiaxing Second Hospital | Jiaxing | Zhejiang | 314000 | China |
| Taizhou Central Hospital Central Hospital | Taizhou | Zhejiang | 318000 | China |
| The 2th School of Medicine ,WMU/The 2th affiliated Hospital and Yuying Children's Hospital of WMU | Wenzhou | Zhejiang | 325027 | 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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