Evaluation of the Clinical Trial of Inhaled TQC3721 Suspension in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Evaluation of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial on the Efficacy and Safety of Inhaled TQC3721 Suspension in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
666
1 country
76
Brief Summary
To evaluate the efficacy of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 chronic-obstructive-pulmonary-disease
Started Sep 2025
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2025
CompletedFirst Posted
Study publicly available on registry
August 29, 2025
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
September 10, 2025
June 1, 2025
1.5 years
August 22, 2025
September 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (15)
Changes in peak FEV1 value
Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Changes in trough FEV1 values
Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Average FEV1 AUC 0-4h
Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
St. George's Respiratory Questionnaire
Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Chronic Obstructive Pulmonary Disease Assessment Test
At 6 weeks, 12 weeks, and 24 weeks of treatment
- +10 more secondary outcomes
Study Arms (2)
TQC3721 Suspension for Inhalation
EXPERIMENTALInhalation of TQC3721 suspension (6mg/2ml), one unit dose twice daily for 24 weeks
Placebo of TQC3721 Suspension for Inhalation
PLACEBO COMPARATORInhalation of TQC3721 placebo, one unit dose twice daily for 24 weeks
Interventions
TQC3721 suspension for inhalation is a Phosphodiesterase3/4 (PDE3/4) inhibitor
Placebo without drug substance
Eligibility Criteria
You may qualify if:
- Sign an informed consent form before screening and fully understand the trial content, process, and potential adverse reactions.
- Comply with the experimental schedule and be able to use the nebulizer inhaler correctly.
- The age range is 40 to 80 years old (including the threshold), and both male and female participants are eligible.
- 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.
- Patients with a clear clinical history and related symptoms of COPD before screening.
- Capable of conducting acceptable and reproducible lung function tests.
- 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.
- Smoking history ≥ 10 pack years.
You may not qualify if:
- A history of life-threatening COPD, including admission to the intensive care unit and/or the need for intubation.
- COPD acute exacerbations requiring systemic hormone therapy within 3 months prior to screening visit (V1 visit) or prior to randomization visit (V2 visit).
- Within the first 6 months of screening, there has been at least 1 hospitalization history due to acute exacerbation of COPD or pneumonia.
- Treatment with antibiotics for upper and/or lower respiratory tract infections within 6 weeks prior to screening or randomization visit (V3 visit).
- Simultaneously suffering from other respiratory diseases.
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (76)
Bozhou People's Hospital
Bozhou, Anhui, 236805, China
Chizhou People's Hospital
Chizhou, Anhui, 247000, China
Chaohu Hospital of Anhui Medical University
Hefei, Anhui, 238000, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
Peolpe's Hospital Of Chongqing Banan District
Chongqing, Chongqing Municipality, 400054, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404000, China
Fuling Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, 408099, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, 363000, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Gansu Provincial Hospital
Lanzhou, Gansu, 730099, China
The Eighth Affiliated Hospital of Southern Medical University（The First people's Hospital of Shunde ）
Foshan, Guangdong, 528300, China
Huizhou Central People's Hospital
Huizhou, Guangdong, 516000, China
Longgang District People's Hospital of Shenzhen
Shenzhen, Guangdong, 518000, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518000, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550000, China
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102, China
Cangzhou Hospital of Integrated TCM- WM·HEBEI
Cangzhou, Hebei, 61013, China
Hebei PetroChina Central Hospital
Langfang, Hebei, 65000, China
The First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 66000, China
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 65799, China
Daqing Longnan Hospital
Daqing, Heilongjiang, 163000, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Qiqihar First Hospital
Qiqihar, Heilongjiang, 161005, China
Jiaozuo Second People's Hospital
Jiaozuo, Henan, 454001, China
Puyang Oilfield General Hospital
Puyang, Henan, 457001, China
The First People's Hospital of Shangqiu
Shangqiu, Henan, 476100, China
Yichang Central People's Hospital
Yichang, Hubei, 443003, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410001, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410028, China
The Central Hospital of Yongzhou
Yongzhou, Hunan, 425002, China
Baotou Central Hospital
Baotou, Inner Mongolia, 14000, China
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 24000, China
Inner Mongolia Medical University Affiliated Hospital
Hohhot, Inner Mongolia, 10000, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, 21100, China
The Fifth People's Hospital of Wuxi
Wuxi, Jiangsu, 214001, China
Jiangyin Hospital of Traditional Chinese Medicine
Wuxi, Jiangsu, 214400, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009, China
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, 225001, China
Yixing People's Hospital
Yixing, Jiangsu, 225000, China
Jiujiang First People's Hospital
Jiujiang, Jiangxi, 332000, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The first hospital of Jilin University
Changchun, Jilin, 130000, China
Central Hospital of Dalian University of Technology
Dalian, Liaoning, 116000, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110021, China
Qinghai Provincial People's Hospital
Xining, Qinghai, 810007, China
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710100, China
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, 712000, China
Binzhou People's Hospital
Binzhou, Shandong, 256610, China
Heze Municipal Hospital
Heze, Shandong, 274031, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272029, China
Weifang NO.2 People's Hospital
Weifang, Shandong, 261041, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200023, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Baoji Central Hospital
Baoji, Shanxi, 721008, China
Changzhi People's Hospital
Changzhi, Shanxi, 46000, China
Yangquan coal Industry(Group) General Hospital
Yangquan, Shanxi, 45000, China
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan, 610000, China
Chengdu Second People's Hospital
Chengdu, Sichuan, 610017, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044, China
Mianyang Central Hospital
Mianyang, Sichuan, 621000, China
Mianyang Hospital of Traditional Chinese Medicine
Mianyang, Sichuan, 621000, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000, China
Suining Central Hospital
Suining, Sichuan, 629099, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Tianjin 4th Center Hospital
Tianjin, Tianjin Municipality, 300140, China
The First Affiliated Hospital of Shihezi University
Shihezi, Xinjiang, 832008, China
The Second Hospital of Jiaxing
Jiaxing, Zhejiang, 314000, China
Jinhua municipal central hospital
Jinhua, Zhejiang, 321000, China
Dongyang People's Hospital
Jinhua, Zhejiang, 322100, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000, China
Shaoxing People's Hospital
Shaoxing, Zhejiang, 312000, China
Taizhou Central Hospital
Taizhou, Zhejiang, 318000, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2025
First Posted
August 29, 2025
Study Start
September 1, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
September 10, 2025
Record last verified: 2025-06