A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT ID: NCT06527144
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
240 participants
INTERVENTIONAL
2024-09-14
2025-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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3mg TQC3721 Suspension for Inhalation (Twice a day)
Two syringes of TQC3721 suspension for inhalation (1ml:1.5mg), twice a day for 4 weeks.
3mg TQC3721 Suspension for Inhalation
TQC3721 suspension for inhalation is target inhibitor.
6mg TQC3721 Suspension for Inhalation (Twice a day)
one syringe of TQC3721 suspension for inhalation（1ml:6mg）and one TQC3721 suspension placebo for inhalation (1ml:0mg), twice a day for 4 weeks.
6mg TQC3721 Suspension for Inhalation
TQC3721 suspension for inhalation is target inhibitor.
Placebo for TQC3721 Suspension for Inhalation (Twice a day)
Two syringes of placebo for TQC3721 suspension for inhalation (1ml:0mg), twice a day for 4 weeks.
Placebo TQC3721 suspension for inhalation
Placebo without active drug substance.
Interventions
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3mg TQC3721 Suspension for Inhalation
TQC3721 suspension for inhalation is target inhibitor.
6mg TQC3721 Suspension for Inhalation
TQC3721 suspension for inhalation is target inhibitor.
Placebo TQC3721 suspension for inhalation
Placebo without active drug substance.
Eligibility Criteria
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Inclusion Criteria
* Male and female subjects aged 40 to 80 years old (including the cut-off value).
* Body mass index (BMI) in the range of 18-30kg/m2 (including the critical value)
* Subjects have no pregnancy plan and voluntarily use effective contraception for at least 1 month from screening to the last use of the study drug.
* Diagnosed as a COPD patient according to the The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 criteria.
* Able to conduct acceptable and reproducible lung function tests.
* COPD clinical stability within the 4 weeks prior to screening visit (V1 visit) and between V1 visit and V2 visit.
* Smoking history ≥ 10 pack years.
Exclusion Criteria
* Screening for COPD acute exacerbations that require systemic hormone therapy prior to the visit.
* Screening for hospitalization history due to COPD within the first 6 months.
* Use antibiotics for respiratory tract infections within 6 weeks prior to screening or randomization visit.
* Chest computed tomography (CT) revealed clinically significant abnormalities and concluded that the abnormalities were not caused by COPD.
* Previous lung resection or lung reduction surgery.
* Pulmonary rehabilitation treatment.
* Previously received TQC3721 treatment.
* Patients who received immunotherapy within the first 4 weeks of the screening period.
* The patient has a history of diseases that are currently beyond their control.
* History or current evidence of cardiovascular disease with clinical significance.
* History of cured or untreated malignant tumors in any organ or system within the past 5 years.
* Screening for clinically significant safety laboratory test outliers determined by the researcher during the visit.
* Those who require oxygen therapy or intermittent oxygen therapy.
* Receive attenuated live vaccine within 28 days prior to randomization, inactivated vaccine within 7 days, or study.
* Planned vaccine recipients during the period.
* Individuals who have participated in any drug or medical device clinical trials prior to screening.
* Researchers believe that there are other situations that are not suitable for participation in the study.
40 Years
80 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fu Yang People'S Hospital
Fuyang, Anhui, China
ChongQing University Fuling Hospital
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Zunyi Medical University Affiliated Hospital
Zunyi, Guizhou, China
Cangzhou Hospital of Integrated Tcm-Wm·Hebei
Cangzhou, Hebei, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Puyang Oilfield General Hospital
Puyang, Henan, China
Shangqiu First People's Hospita
Shangqiu, Henan, China
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, China
Wuxi Fifth People's Hospital
Wuxi, Jiangsu, China
Yixing People'S Hospital
Wuxi, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Siping Central People's Hospital
Siping, Jilin, China
Genertec Liaoyou Gem Flower Hospital
Panjin, Liaoning, China
Heze Municipal Hospital
Heze, Shandong, China
Shanghai JiaoTong University of medicine Ruijin Hospital
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Suining Central Hospital
Suining, Sichuan, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
TianJin 4th Center Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Shihezi University
Shihezi, Xinjiang, China
Wenzhou University Affiliated Second Hospital
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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TQC3721-II-03
Identifier Type: -
Identifier Source: org_study_id
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