A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT Number: NCT06527144
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Interventions: DRUG: 3mg TQC3721 Suspension for Inhalation|DRUG: 6mg TQC3721 Suspension for Inhalation|DRUG: Placebo TQC3721 suspension for inhalation
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2025-12
Locations: Fu Yang People'S Hospital, Fuyang, Anhui, 236000, China|ChongQing University Fuling Hospital, Chongqing, Chongqing, 400000, China|The Second Affiliated Hospital of Xiamen Medical College, Xiamen, Fujian, 361021, China|The First Hospital of Lanzhou University, Lanzhou, Gansu, 730000, China|The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, 510120, China|The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, 530016, China|Zunyi Medical University Affiliated Hospital, Zunyi, Guizhou, 563000, China|Cangzhou Hospital of Integrated Tcm-Wm·Hebei, Cangzhou, Hebei, 61012, China|The Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050051, China|Puyang Oilfield General Hospital, Puyang, Henan, 457001, China|Shangqiu First People's Hospita, Shangqiu, Henan, 476000, China|Chifeng Municipal Hospital, Chifeng, Inner Mongolia Autonomous Region, 024000, China|Wuxi Fifth People's Hospital, Wuxi, Jiangsu, 214000, China|Yixing People'S Hospital, Wuxi, Jiangsu, 214200, China|Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, 225000, China|Jiangxi Provincial People's Hospital, Nanchang, Jiangxi, 330006, China|The First Hospital of Jilin University, Changchun, Jilin, 130031, China|Siping Central People's Hospital, Siping, Jilin, 136099, China|Genertec Liaoyou Gem Flower Hospital, Panjin, Liaoning, 100007, China|Heze Municipal Hospital, Heze, Shandong, 274031, China|Shanghai JiaoTong University of medicine Ruijin Hospital, Shanghai, Shanghai, 20025, China|Shanxi Bethune Hospital, Taiyuan, Shanxi, 030000, China|West China Hospital of Sichuan University, Chengdu, Sichuan, 610044, China|Suining Central Hospital, Suining, Sichuan, 629000, China|Tianjin Medical University General Hospital, Tianjin, Tianjin, 300041, China|TianJin 4th Center Hospital, Tianjin, Tianjin, 300142, China|The First Affiliated Hospital of Shihezi University, Shihezi, Xinjiang, 832000, China|Wenzhou University Affiliated Second Hospital, Wenzhou, Zhejiang, 325027, China

Summary:
To evaluate the efficacy and safety of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD)

Primary Outcome Measures: Change of the maximum value of Forced Expiratory Volume in the first second (FEV1), Change of the maximum value of FEV1 was determined from baseline to four weeks after treatment., From baseline to four weeks after treatment
Secondary Outcome Measures: Change of the mean value of FEV1, Compared with baseline, the mean value of FEV1 was changed within 3 hours and 12 hours after morning medication at 4 weeks of treatment., From baseline to four weeks after treatment|Changes in peak FEV1 values,trough FEV1 values, mean value within 3 hours after administration, Compared with baseline, Changes in peak FEV1 values,trough FEV1 values, mean value within 3 hours after administration after 2 weeks of treatment., From baseline to two weeks after treatment|Rescue medication, Frequency of Rescue medication use during the study compared to placebo group, From baseline to four weeks after administration|Adverse Events (AE), The number, frequency, incidence, and severity of adverse events, serious adverse events, and adverse events associated with investigational drugs (including investigational drugs and control drugs), as well as abnormal laboratory indicators were evaluated., From baseline to safety visit (about 5 weeks after first dosing).|Changes in the peak value of FEV1，mean value of FEV1 within 3 hours and 12 hours after administration, Compared with baseline, changes in the peak value of FEV1 after 1 day of treatment, and the mean value of FEV1 within 3 hours and 12 hours after administration., From baseline to 1day after treatment|Changes of FEV1 at each time point, Changes in series FEV1 at each time point within 12 hours after morning administration on day 1 of treatment (after first dosing) compared to baseline., From baseline to 1day after treatment|Changes in peak value of FEV1 and the mean value of FEV1 within 3 hours and 12 hours, To evaluate the change in FEV1 peak value and FEV1 mean value within 3 hours and 12 hours after 4 weeks of treatment compared with 1 day of treatment (after first administration), From 1day after treatment to 4 weeks after treatment|Changes in Morning Valley FEV1, Changes in Morning Valley FEV1 after 4 weeks of treatment compared with baseline, From baseline to four weeks after treatment|Changes in Modified Medical Research Council (mMRC) Dyspnea Scale Score, mMRC Dyspnea Scale Score's total score is 0-4 points, with the higher score meaning the more severe symptoms., Changes in mMRC score after 2 and 4 weeks of treatment compared with baseline|Chronic obstructive pulmonary disease Assessment Test (CAT), There are 8 questions in the CAT, and each question is scored 0-5 points, with the higher score meaning the more severe symptoms, Changes in CAT assessment after 2 and 4 weeks of treatment compared with baseline|St. George's Respiratory Questionnaire (SGRQ), SGRQ has three parts: symptoms, abilities, and effects, and is used to comprehensively measure the physical, mental, and social status of COPD patients., Changes in SGRQ after 2 and 4 weeks of treatment compared with baseline|Basic Dyspnea Index (BDI), BDI has three levels: functional impairment, magnitude of task, and magnitude of effort. Each level is rated from 0 (severe) to 4(No damage)., Changes in BDI after 2 and 4 weeks of treatment compared with baseline.|Transitional Dyspnea Index (TDI), TDI has three levels:changes in functional impairment, changes in magnitude of task, changes in magnitude of effort,. Scores in each area range from -3 (significant deterioration) to 0 (no change) to +3 (significant improvement)., Changes in TDI after 2 and 4 weeks of treatment compared with baseline