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This study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of TQC2731 injection (420 mg Q4W) in adult subjects with inadequately controlled severe asthma. A total of 660 subjects are expected to be enrolled, with subjects randomized in a 1:1 ratio to receive either TQC2731 (420 mg Q4W) or placebo (Q4W) via subcutaneous (SC) administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQC2731 injection | Experimental | TQC2731 injection, 4 weeks as a treatment cycle. Study drug administration from Day 0 up to Week 48. |
|
| Placebo | Placebo Comparator | Placebo,4 weeks as a treatment cycle.Study drug administration from Day 0 up to Week 48. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQC2731 injection | Drug | TQC2731 injection can specifically bind to the Thymic Stromal Lymphopoietin (TSLP) protein, blocking TSLP-dependent downstream signaling expression in engineered cells and inhibiting the production of inflammatory cytokines. |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized incidence of asthma exacerbations | Annualized incidence of asthma exacerbations (AAER) during the 52-week treatment period. | From the first day of dosing to the completion of 52 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The change in forced expiratory volume in 1 second (FEV1) | At Week 52, the change from baseline in forced expiratory volume in 1 second (FEV1) prior to dosing and before the use of a bronchodilator (pre-BD administration). | Week 52 before dosing and before the use of bronchodilators (pre-Bronchodilator (pre-BD) administration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinping Zheng, Doctor | Contact | 18928868238 | jpzhenggy@163.com | |
| Qingling Zhang, Doctor | Contact | 13609068871 | zqling68@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The People's Hospital of Bozhou | Not yet recruiting | Bozhou | Anhui | 236000 | China |
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| Placebo | Drug | Placebo without drug substance. |
|
| Change in total score of standardized asthma quality of life questionnaire |
Change from baseline in standardized asthma quality of life questionnaire (AQLQ(S)+12) total score at week 52. Scores above 5 points indicate a relatively good quality of life, while scores below 3 points suggest a relatively poor quality of life. |
| From baseline to week 52 |
| Change in Asthma Control Questionnaire-6 (ACQ-6) score | Mean change from baseline in weekly mean asthma symptom diary score at week 52, , The higher the score, the more severe the asthma symptoms. | From baseline to week 52 |
| Mean change in weekly mean asthma symptom diary score | Mean change from baseline in weekly mean asthma symptom diary score at week 52 | From baseline to week 52 |
| Change in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire score | Change from baseline in European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire score at Week 52, a higher score indicates a better quality of life. | From baseline to week 52 |
| Change in mean rescue medication use, average peak expiratory flow rate (PEF) in the morning and night | Change from baseline in the average weekly dose of rescue medication and the average peak expiratory flow rate (PEF) per week in the morning and night, respectively | From baseline to week 52 |
| Changes in exhaled nitric oxide Fractional exhaled nitric oxide (FENO) (ppb), peripheral blood eosinophils, total serum Immunoglobulin E (IgE). | Change from baseline in exhaled nitric oxide FENO (ppb) at week 52. | From baseline to week 52 |
| Changes in peripheral blood eosinophils | Change from baseline in peripheral blood eosinophils at week 52. | From baseline to week 52 |
| Changes in total serum IgE | Change from baseline in total serum IgE at week 52. | From baseline to week 52 |
| Time to first asthma exacerbation | Time to first asthma exacerbation | Baseline to week 64 |
| Proportion of subjects with ≥1 asthma exacerbation | Proportion of subjects with ≥1 asthma exacerbation | Baseline to week 64 |
| Number of days of glucocorticoid use due to acute exacerbations | Number of days of glucocorticoid use due to acute exacerbations | Baseline to week 64 |
| Average amount of hormone used per acute exacerbation (prednisone equivalent) | Average amount of hormone used per acute exacerbation (prednisone equivalent) | Baseline to week 64 |
| Incidence of anti-drug antibodies (ADAs) in subjects | Immunogenicity: Incidence of anti-drug antibodies (ADAs) in subjects and their titers. | Baseline to week 64 |
| Incidence of neutralizing antibodies(NAB) in subjects | Immunogenicity: Incidence of neutralizing antibodies (NAB). | Baseline to week 64 |
| Anhui Chest Hoispital | Not yet recruiting | Hefei | Anhui | 230022 | China |
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| The First Affiliated Hospital of Anhui Medical University | Not yet recruiting | Hefei | Anhui | 230022 | China |
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| Lu'an People's Hospital of Anhui Province | Not yet recruiting | Lu'an | Anhui | 237000 | China |
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| Tongling People's Hospital | Not yet recruiting | Tongling | Anhui | 244000 | China |
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| Peking University First Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100000 | China |
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| Beijing No.6 Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100007 | China |
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| The First Affiliated Hospital of Xiamen University | Not yet recruiting | Xiamen | Fujian | 361000 | China |
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| Zhangzhou Municipal Hospital of Fujian | Not yet recruiting | Zhangzhou | Fujian | 363000 | China |
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| The First Hospital of Lanzhou University | Not yet recruiting | Lanzhou | Gansu | 730000 | China |
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| The Second Hospital & Clinical Medical School,Lanzhou University | Not yet recruiting | Lanzhou | Gansu | 730000 | China |
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| The Eighth Afliated Hospital of Southern Medical University The First people's Hospital of Shunde | Not yet recruiting | Foshan | Guangdong | 528300 | China |
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| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| Guangdong Provincial Hospital of Traditional Chinese Medicine | Not yet recruiting | Guangzhou | Guangdong | 510120 | China |
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| Guangzhou First People's Hospital | Not yet recruiting | Guangzhou | Guangdong | 510180 | China |
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| Third People's Hospital of Huizhou | Not yet recruiting | Huizhou | Guangdong | 516002 | China |
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| Zhongshan City People's Hospital | Not yet recruiting | Zhongshan | Guangdong | 528403 | China |
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| The Affiliated Hospital of Medical University | Not yet recruiting | Guilin | Guangxi | 541000 | China |
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| Guilin People'S Hospital | Not yet recruiting | Guilin | Guangxi | 541002 | China |
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| Guizhou Provincial People's Hospital | Not yet recruiting | Guiyang | Guizhou | 550000 | China |
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| The First Affiliated Hospital of Hainan Medical University | Not yet recruiting | Haikou | Hainan | 570102 | China |
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| Cangzhou Hospital of Integrated TCM-WM·Hebei | Not yet recruiting | Cangzhou | Hebei | 061000 | China |
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| Xingtai People's Hospital | Not yet recruiting | Xingtai | Hebei | 054001 | China |
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| Da Qing Long Nan Hospital | Not yet recruiting | Daqing | Heilongjiang | 163453 | China |
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| The Fourth Affiliated Hospital of Harbin Medical University | Not yet recruiting | Harbin | Heilongjiang | 150001 | China |
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| The First Hospital of Qiqihar | Not yet recruiting | Qiqihar | Heilongjiang | 161000 | China |
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| The People's Hospital of Anyang | Not yet recruiting | Anyang | Henan | 455099 | China |
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| The Second People's Hospital of Jiaozuo City | Not yet recruiting | Jiaozuo | Henan | 454001 | China |
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| Luo Yang Dong Fang People's Hospital | Not yet recruiting | Luoyang | Henan | 471003 | China |
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| Xinxiang Central Hospital | Not yet recruiting | Xinxiang | Henan | 453000 | China |
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| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | 450003 | China |
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| Zhengzhou Central Hospital | Not yet recruiting | Zhengzhou | Henan | 450007 | China |
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| Zhoukou Central hospital | Not yet recruiting | Zhoukou | Henan | 466000 | China |
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| Enshi Tujia and Miao Autonomous Prefecture Central Hospital | Not yet recruiting | Enshi | Hubei | 445000 | China |
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| The Central Hospital of Wuhan | Not yet recruiting | Wuhan | Hubei | 430000 | China |
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| Changsha Central Hospital | Not yet recruiting | Changsha | Hunan | 410000 | China |
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| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410011 | China |
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| Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University) | Not yet recruiting | Changsha | Hunan | 410021 | China |
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| Loudi central hospital | Not yet recruiting | Loudi | Hunan | 417000 | China |
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| Baotou Central Hospital | Not yet recruiting | Baotou | Inner Mongolia | 014040 | China |
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| The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology | Not yet recruiting | Baotou | Inner Mongolia | 14000 | China |
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| Chifeng Municipal Hospital | Not yet recruiting | Chifeng | Inner Mongolia | 024099 | China |
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| The Affiliated Hospital of Inner Mongolia Medical University | Not yet recruiting | Hohhot | Inner Mongolia | 100000 | China |
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| Inner Mongolia Autonomous Region People's Hospital | Not yet recruiting | Hohhot | Inner Mongolia | 100017 | China |
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| Affiliated Hospital of Jiangsu University | Not yet recruiting | Nanjing | Jiangsu | 210029 | China |
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| Wuxi Second People's Hospital | Not yet recruiting | Wuxi | Jiangsu | 214002 | China |
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| The Affiliated Hospital of Xuzhou Medical University | Not yet recruiting | Xuzhou | Jiangsu | 221000 | China |
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| Xuzhou Central Hospital | Not yet recruiting | Xuzhou | Jiangsu | 221000 | China |
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| Northern Jiangsu People's Hospital | Not yet recruiting | Yangzhou | Jiangsu | 225001 | China |
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| Jiangsu University Affiliated Hospital | Not yet recruiting | Zhenjiang | Jiangsu | 212001 | China |
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| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330038 | China |
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| Pingxiang People's Hospital | Not yet recruiting | Pingxiang | Jiangxi | 337055 | China |
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| Jilin University Second Hospital | Not yet recruiting | Changchun | Jilin | 130000 | China |
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| The First Hospital of Jlin University | Not yet recruiting | Changchun | Jilin | 130000 | China |
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| Gansu Provincial Hospital | Not yet recruiting | Gansu | Lanzhou | 730000 | China |
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| Dalian Municipal Central Hospital | Not yet recruiting | Dalian | Liaoning | 116021 | China |
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| Genertec Liaoyou Gem Flower Hospital | Not yet recruiting | Panjin | Liaoning | 124000 | China |
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| Shengjing Hospital affiliated to China Medical University | Not yet recruiting | Shenyang | Liaoning | 110000 | China |
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| Shengjing Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110000 | China |
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| People's Liberation Army North Theater General Hospital | Not yet recruiting | Shenyang | Liaoning | 130012 | China |
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| The First People's Hospital of Yinchuan | Not yet recruiting | Yinchuan | Ningxia | 750001 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | 710000 | China |
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| The First Affiliated Hospital of Xi'an Medical Universi | Not yet recruiting | Xi'an | Shaanxi | 710000 | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University | Not yet recruiting | Xi'an | Shaanxi | 710000 | China |
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| Xi'an International Medical Center Hospital | Not yet recruiting | Xi'an | Shaanxi | 710000 | China |
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| Xi'an People's Hospital (Xi'an Fourth Hospital) | Not yet recruiting | Xi'an | Shaanxi | 710004 | China |
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| Heze Municipal Hospital | Not yet recruiting | Heze | Shandong | 274031 | China |
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| Central Hospital Affiliated to Shandong First Medical University | Not yet recruiting | Jinan | Shandong | 250000 | China |
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| Affiliated Hospital of Jining Medical Hospital | Not yet recruiting | Jining | Shandong | 272000 | China |
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| The Affiliated Hospital of Qingdao University | Not yet recruiting | Qingdao | Shandong | 266003 | China |
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| The Second Affiliated Hospital of Shandong First Medical University | Not yet recruiting | Tai’an | Shandong | 271000 | China |
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| Weifang NO.2 People's Hospital | Not yet recruiting | Weifang | Shandong | 261041 | China |
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| Yantai Yuhuangding Hospital | Not yet recruiting | Yantai | Shandong | 264099 | China |
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| Zaozhuang Municipal Hospital | Not yet recruiting | Zaozhuang | Shandong | 277000 | China |
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| Zibo Central Hospital | Not yet recruiting | Zibo | Shandong | 250036 | China |
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| Rui Jin Hospital Shanghai Jiaotong University School of Medical | Not yet recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| Fudan University Affiliated Zhongshan Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Shanghai General Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200080 | China |
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| Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center | Not yet recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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| Wusong Central Hospital, Baoshan District, Shanghai | Recruiting | Shanghai | Shanghai Municipality | 200940 | China |
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| Jincheng General Hospital | Not yet recruiting | Jincheng | Shanxi | 48000 | China |
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| Shanxi Bethune Hospital | Not yet recruiting | Taiyuan | Shanxi | 030032 | China |
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| No.215 Hospital of Shaanxi Nuclear Industry | Not yet recruiting | Xianyang | Shanxi | 712000 | China |
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| Yangquan Coal Industry Group General Hospital | Not yet recruiting | Yangquan | Shanxi | 45000 | China |
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| West China Hospital, Sichuan University | Not yet recruiting | Chengdu | Sichuan | 610000 | China |
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| Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610072 | China |
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| Chengdu Fifth People's Hospital | Not yet recruiting | Chengdu | Sichuan | 611130 | China |
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| Suining Central Hospital | Not yet recruiting | Suining | Sichuan | 629000 | China |
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| Yibin Second People's Hospital | Not yet recruiting | Yibin | Sichuan | 644000 | China |
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| Tianjin Medical University General Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300052 | China |
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| Tianjin 4th Center Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300140 | China |
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| The First Affiliated Hospital of Shihezi University | Not yet recruiting | Shihezi | Xinjiang | 832008 | China |
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| First Affiliated Hospital of Xinjiang Medical University | Not yet recruiting | Ürümqi | Xinjiang | 830000 | China |
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| People's Hospital of Xinjiang Uygur Autonomous Region | Not yet recruiting | Ürümqi | Xinjiang | 830000 | China |
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| The First People's Hospital of Yunnan Province | Not yet recruiting | Kunming | Yunnan | 650000 | China |
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| The First Affiliated of Kumming Medical University | Not yet recruiting | Kunming | Yunnan | 652700 | China |
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| The People's Hospital of Yuyao | Not yet recruiting | Yuyao | Zhejaing | 315400 | China |
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| Jinhua Municipal Central Hospital | Not yet recruiting | Jinhua | Zhejiang | 321000 | China |
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| The First Affiliated Hospital of Ningbo University | Not yet recruiting | Ningbo | Zhejiang | 315020 | China |
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| Taizhou Central Hospital(Taizhou University Hospital) | Not yet recruiting | Taizhou | Zhejiang | 318000 | China |
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| The 2nd School of Medicine,WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU | Not yet recruiting | Wenzhou | Zhejiang | 325000 | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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