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To evaluate the efficacy of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQC3721 Suspension for Inhalation | Experimental | Inhalation of TQC3721 suspension (6mg/2ml), one unit dose twice daily for 24 weeks |
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| Placebo of TQC3721 Suspension for Inhalation | Placebo Comparator | Inhalation of TQC3721 placebo, one unit dose twice daily for 24 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQC3721 Suspension for inhalation | Drug | TQC3721 suspension for inhalation is a Phosphodiesterase3/4 (PDE3/4) inhibitor |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change in the area under the curve (AUC) of Forced Expiratory Volume in 1 second (FEV1) | Change from baseline in mean FEV1 AUC over 0-12 hours after 12 weeks of treatment. | Baseline to 12 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in peak FEV1 value | Changes from baseline in peak FEV1 within 4 hours after morning dosing at Weeks 6, 12, and 24 of treatment. | Baseline to 6 weeks, 12 weeks, 24 weeks after treatment |
| Changes in trough FEV1 values |
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Inclusion Criteria:
Exclusion Criteria:
11.Previously received TQC3721 treatment. 12.Patients who received immunosuppressant therapy within 4 weeks prior to the screening period 13.In the investigator's assessment, patients are unable to discontinue the prohibited drugs specified in the protocol during the screening and treatment phases of the study; 14.Patients with a history of uncontrolled current diseases that the investigator judges to be clinically significant; 15.A history or current evidence of clinically significant cardiovascular or cerebrovascular diseases; 16.A history of malignant tumors (cured or uncured) in any organ or system within the past 5 years; 17.Intolerance or allergy to salbutamol or other inhaled bronchodilator therapies for COPD; 18.Patients requiring long-term oxygen therapy; 19.Female subjects who are currently pregnant, breastfeeding, or planning to become pregnant during the study period after enrollment; 20.Having participated in any clinical trial of drugs or medical devices within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit; 21.Other conditions deemed unsuitable for participation in the study by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weimin Li, Doctor | Contact | 028-85423998 | weimin003@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bozhou People's Hospital | Bozhou | Anhui | 236805 | China |
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| Placebo of TQC3721 Suspension for Inhalation | Drug | Placebo without drug substance |
|
Changes from baseline in morning trough FEV1 at Weeks 6, 12, and 24 of treatment.
| Baseline to 6 weeks, 12 weeks, 24 weeks after treatment |
| Average FEV1 AUC 0-4h | Change from baseline in the average FEV1 AUC 0-4h within 4 hours after morning dosing at 6, 12, and 24 weeks of treatment. | Baseline to 6 weeks, 12 weeks, 24 weeks after treatment |
| St. George's Respiratory Questionnaire | Changes in St. George's Respiratory Questionnaire (SGRQ) total scores from baseline at 6, 12, and 24 weeks of treatment. | Baseline to 6 weeks, 12 weeks, 24 weeks after treatment |
| Chronic Obstructive Pulmonary Disease Assessment Test | Self-assessment for Patients with COPD:Numbers 0 to 5 indicate the severity (with 0 being the mildest and 5 being the most severe). | At 6 weeks, 12 weeks, and 24 weeks of treatment |
| Average FEV1 AUC (6-12h) | Change from baseline in mean FEV₁ AUC (6-12 h) at Week 12 following dosing. | Baseline to 12 weeks after treatment |
| Annual rate of acute exacerbation of COPD | The annualized rate of acute exacerbation of moderate/severe COPD after 24 weeks of treatment. | Baseline to 24 weeks after treatment |
| Time of first acute exacerbation of moderate/severe COPD | The time of the first acute exacerbation of moderate/severe COPD within 24 weeks of treatment. | Baseline to 24 weeks after treatment |
| Adverse event (AE) | The number of participants with AEs, serious dverse event (SAEs), drug-related AEs, and abnormal lab results. | D-28 to within 25 weeks of treatment |
| Assessment of respiratory symptoms in COPD | Change from baseline in weekly mean Evaluating Respiratory Symptoms in COPD total score | Baseline to 6 weeks, 12 weeks, 24 weeks after treatment |
| Transition Dyspnea Index (TDI) score | Change in Transition Dyspnea Index (TDI) score relative to Baseline Dyspnea Index (BDI) score | Baseline to 6 weeks, 12 weeks, 24 weeks after treatment |
| Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score | Change in Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score from baseline | Baseline to 6 weeks, 12 weeks, 24 weeks after treatment |
| Change from baseline in rescue medication use | Changes from baseline in rescue medication use during treatment at Weeks 6, 12, and 24 versus the placebo group | Baseline to 6 weeks, 12 weeks, 24 weeks after treatment. |
| Interleukin-6 (IL-6), Interleukin-8 (IL-8), and C-reactive protein (CRP) at Week 12 and Week 24 | IL-6, IL-8, and C-reactive protein (CRP) at Week 12 and Week 24. The elevated serum C-reactive protein (CRP) levels in patients with chronic obstructive pulmonary disease (COPD) are primarily associated with pulmonary inflammatory responses. | At Week 12 and Week 24 |
| Plasma drug peak concentration | Perform Pharmacokinetics (PK) analysis of TQC3721 blood drug concentration data at baseline, week 6, and week 12 to evaluate the PK characteristics of TQC3721 in COPD patients. | Day 1: 0.5 hour after-dose, Week 6: 1 hour pre-dose, 0.5 hour after-dose; Week 12: 1 hour pre-dose, 0.5 hour after-dose |
| Chizhou People's Hospital | Chizhou | Anhui | 247000 | China |
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| Chaohu Hospital of Anhui Medical University | Hefei | Anhui | 238000 | China |
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| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400010 | China |
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| Peolpe's Hospital Of Chongqing Banan District | Chongqing | Chongqing Municipality | 400054 | China |
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| Chongqing University Three Gorges Hospital | Chongqing | Chongqing Municipality | 404000 | China |
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| Fuling Hospital Affiliated to Chongqing University | Chongqing | Chongqing Municipality | 408099 | China |
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| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350000 | China |
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| Zhangzhou Municipal Hospital of Fujian Province | Zhangzhou | Fujian | 363000 | China |
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| The First Hospital of Lanzhou University | Lanzhou | Gansu | 730000 | China |
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| Gansu Provincial Hospital | Lanzhou | Gansu | 730099 | China |
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| The Eighth Affiliated Hospital of Southern Medical University(The First people's Hospital of Shunde ) | Foshan | Guangdong | 528300 | China |
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| Huizhou Central People's Hospital | Huizhou | Guangdong | 516000 | China |
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| Longgang District People's Hospital of Shenzhen | Shenzhen | Guangdong | 518000 | China |
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| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518000 | China |
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| Guizhou Provincial People's Hospital | Guiyang | Guizhou | 550000 | China |
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| The First Affiliated Hospital of Hainan Medical University | Haikou | Hainan | 570102 | China |
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| Cangzhou Hospital of Integrated TCM- WM·HEBEI | Cangzhou | Hebei | 61013 | China |
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| Hebei PetroChina Central Hospital | Langfang | Hebei | 65000 | China |
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| The First Hospital of Qinhuangdao | Qinhuangdao | Hebei | 66000 | China |
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| Hebei Medical University Third Hospital | Shijiazhuang | Hebei | 65799 | China |
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| Daqing Longnan Hospital | Daqing | Heilongjiang | 163000 | China |
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| The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
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| Qiqihar First Hospital | Qiqihar | Heilongjiang | 161005 | China |
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| Jiaozuo Second People's Hospital | Jiaozuo | Henan | 454001 | China |
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| Puyang Oilfield General Hospital | Puyang | Henan | 457001 | China |
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| The First People's Hospital of Shangqiu | Shangqiu | Henan | 476100 | China |
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| Yichang Central People's Hospital | Yichang | Hubei | 443003 | China |
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| Hunan Provincial People's Hospital | Changsha | Hunan | 410001 | China |
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| Xiangya Hospital of Central South University | Changsha | Hunan | 410028 | China |
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| The Central Hospital of Yongzhou | Yongzhou | Hunan | 425002 | China |
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| Baotou Central Hospital | Baotou | Inner Mongolia | 14000 | China |
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| Chifeng Municipal Hospital | Chifeng | Inner Mongolia | 24000 | China |
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| Inner Mongolia Medical University Affiliated Hospital | Hohhot | Inner Mongolia | 10000 | China |
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| Nanjing Jiangning Hospital | Nanjing | Jiangsu | 21100 | China |
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| The Fifth People's Hospital of Wuxi | Wuxi | Jiangsu | 214001 | China |
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| Jiangyin Hospital of Traditional Chinese Medicine | Wuxi | Jiangsu | 214400 | China |
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| Xuzhou Central Hospital | Xuzhou | Jiangsu | 221009 | China |
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| Subei People's Hospital of Jiangsu province | Yangzhou | Jiangsu | 225001 | China |
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| Yixing People's Hospital | Yixing | Jiangsu | 225000 | China |
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| Jiujiang First People's Hospital | Jiujiang | Jiangxi | 332000 | China |
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| Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | 330006 | China |
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| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
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| The first hospital of Jilin University | Changchun | Jilin | 130000 | China |
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| Central Hospital of Dalian University of Technology | Dalian | Liaoning | 116000 | China |
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| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110021 | China |
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| Qinghai Provincial People's Hospital | Xining | Qinghai | 810007 | China |
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| Xi'an International Medical Center Hospital | Xi'an | Shaanxi | 710100 | China |
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| Yan'an University Xianyang Hospital | Xianyang | Shaanxi | 712000 | China |
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| Binzhou People's Hospital | Binzhou | Shandong | 256610 | China |
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| Heze Municipal Hospital | Heze | Shandong | 274031 | China |
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| Affiliated Hospital of Jining Medical University | Jining | Shandong | 272029 | China |
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| Weifang NO.2 People's Hospital | Weifang | Shandong | 261041 | China |
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| Yantai Yuhuangding Hospital | Yantai | Shandong | 264099 | China |
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| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200023 | China |
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| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
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| Baoji Central Hospital | Baoji | Shanxi | 721008 | China |
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| Changzhi People's Hospital | Changzhi | Shanxi | 46000 | China |
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| Yangquan coal Industry(Group) General Hospital | Yangquan | Shanxi | 45000 | China |
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| The First Affiliated Hospital of Chengdu Medical College | Chengdu | Sichuan | 610000 | China |
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| Chengdu Second People's Hospital | Chengdu | Sichuan | 610017 | China |
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| West China Hospital of Sichuan University | Chengdu | Sichuan | 610044 | China |
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| Mianyang Central Hospital | Mianyang | Sichuan | 621000 | China |
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| Mianyang Hospital of Traditional Chinese Medicine | Mianyang | Sichuan | 621000 | China |
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| Affiliated Hospital of North Sichuan Medical College | Nanchong | Sichuan | 637000 | China |
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| Suining Central Hospital | Suining | Sichuan | 629099 | China |
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| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
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| Tianjin 4th Center Hospital | Tianjin | Tianjin Municipality | 300140 | China |
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| The First Affiliated Hospital of Shihezi University | Shihezi | Xinjiang | 832008 | China |
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| The Second Hospital of Jiaxing | Jiaxing | Zhejiang | 314000 | China |
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| Jinhua municipal central hospital | Jinhua | Zhejiang | 321000 | China |
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| Dongyang People's Hospital | Jinhua | Zhejiang | 322100 | China |
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| The First Affiliated Hospital of Ningbo University | Ningbo | Zhejiang | 315000 | China |
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| Shaoxing People's Hospital | Shaoxing | Zhejiang | 312000 | China |
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| Taizhou Central Hospital | Taizhou | Zhejiang | 318000 | China |
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| The Second Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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