Evaluation of the Clinical Trial of Inhaled TQC3721 Suspension in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
NCT ID: NCT07147946
Last Updated: 2025-09-10
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE3
666 participants
INTERVENTIONAL
2025-09-30
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT06527144
A Phase II Clinical Trial on the Efficacy and Safety of TQC3721 Inhalation Powder
NCT07252908
A Phase II Clinical Trial of TQC3721 Suspension for Inhalation
NCT05292196
A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease.
NCT05987371
A Clinical Trial of TQC3721 Suspension for Inhalation
NCT05051930
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TQC3721 Suspension for Inhalation
Inhalation of TQC3721 suspension (6mg/2ml), one unit dose twice daily for 24 weeks
TQC3721 Suspension for inhalation
TQC3721 suspension for inhalation is a Phosphodiesterase3/4 (PDE3/4) inhibitor
Placebo of TQC3721 Suspension for Inhalation
Inhalation of TQC3721 placebo, one unit dose twice daily for 24 weeks
Placebo of TQC3721 Suspension for Inhalation
Placebo without drug substance
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TQC3721 Suspension for inhalation
TQC3721 suspension for inhalation is a Phosphodiesterase3/4 (PDE3/4) inhibitor
Placebo of TQC3721 Suspension for Inhalation
Placebo without drug substance
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Comply with the experimental schedule and be able to use the nebulizer inhaler correctly.
3. The age range is 40 to 80 years old (including the threshold), and both male and female participants are eligible.
4. The subjects have no pregnancy plans and voluntarily take effective contraceptive measures for at least one month from screening to the last use of the study drug.
5. Patients with a clear clinical history and related symptoms of COPD before screening.
6. Capable of conducting acceptable and reproducible lung function tests.
7. COPD clinical stability (no moderate to severe COPD acute exacerbation) within the 4 weeks prior to screening visit (V1 visit) and between V1 visit and V2 visit.
8. Smoking history ≥ 10 pack years.
Exclusion Criteria
2. COPD acute exacerbations requiring systemic hormone therapy within 3 months prior to screening visit (V1 visit) or prior to randomization visit (V2 visit).
3. Within the first 6 months of screening, there has been at least 1 hospitalization history due to acute exacerbation of COPD or pneumonia.
4. Treatment with antibiotics for upper and/or lower respiratory tract infections within 6 weeks prior to screening or randomization visit (V3 visit).
5. Simultaneously suffering from other respiratory diseases.
6. Chest computed tomography (CT) revealed clinically significant abnormalities and concluded that the abnormalities were not caused by COPD.
7. Previous lung resection or lung reduction surgery.
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.
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bozhou People's Hospital
Bozhou, Anhui, China
Chizhou People's Hospital
Chizhou, Anhui, China
Chaohu Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Peolpe's Hospital Of Chongqing Banan District
Chongqing, Chongqing Municipality, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
Fuling Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Gansu Provincial Hospital
Lanzhou, Gansu, China
The Eighth Affiliated Hospital of Southern Medical University（The First people's Hospital of Shunde ）
Foshan, Guangdong, China
Huizhou Central People's Hospital
Huizhou, Guangdong, China
Longgang District People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Cangzhou Hospital of Integrated TCM- WM·HEBEI
Cangzhou, Hebei, China
Hebei PetroChina Central Hospital
Langfang, Hebei, China
The First Hospital of Qinhuangdao
Qinhuangdao, Hebei, China
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, China
Daqing Longnan Hospital
Daqing, Heilongjiang, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Qiqihar First Hospital
Qiqihar, Heilongjiang, China
Jiaozuo Second People's Hospital
Jiaozuo, Henan, China
Puyang Oilfield General Hospital
Puyang, Henan, China
The First People's Hospital of Shangqiu
Shangqiu, Henan, China
Yichang Central People's Hospital
Yichang, Hubei, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Central Hospital of Yongzhou
Yongzhou, Hunan, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, China
Inner Mongolia Medical University Affiliated Hospital
Hohhot, Inner Mongolia, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
The Fifth People's Hospital of Wuxi
Wuxi, Jiangsu, China
Jiangyin Hospital of Traditional Chinese Medicine
Wuxi, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, China
Yixing People's Hospital
Yixing, Jiangsu, China
Jiujiang First People's Hospital
Jiujiang, Jiangxi, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The first hospital of Jilin University
Changchun, Jilin, China
Central Hospital of Dalian University of Technology
Dalian, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Qinghai Provincial People's Hospital
Xining, Qinghai, China
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, China
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, China
Binzhou People's Hospital
Binzhou, Shandong, China
Heze Municipal Hospital
Heze, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Weifang NO.2 People's Hospital
Weifang, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Baoji Central Hospital
Baoji, Shanxi, China
Changzhi People's Hospital
Changzhi, Shanxi, China
Yangquan coal Industry(Group) General Hospital
Yangquan, Shanxi, China
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan, China
Chengdu Second People's Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Mianyang Hospital of Traditional Chinese Medicine
Mianyang, Sichuan, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, 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
The Second Hospital of Jiaxing
Jiaxing, Zhejiang, China
Jinhua municipal central hospital
Jinhua, Zhejiang, China
Dongyang People's Hospital
Jinhua, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Shaoxing People's Hospital
Shaoxing, Zhejiang, China
Taizhou Central Hospital
Taizhou, Zhejiang, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TQC3721-III-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.