Evaluation of the Inhaled TQC3721 Suspension in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Evaluation of Safety Profile in a Cohort Study of Inhaled TQC3721 Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
800
1 country
54
Brief Summary
To evaluate the safety of inhaled TQC3721 Suspension in patients with moderate to severe Chronic Obstructive Pulmonary Disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 chronic-obstructive-pulmonary-disease
Started Apr 2026
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2026
CompletedFirst Posted
Study publicly available on registry
March 11, 2026
CompletedStudy Start
First participant enrolled
April 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
September 28, 2026
March 1, 2026
10 months
March 7, 2026
September 24, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Queue A: Extended study period: Weeks 24-50; Queue B: At week 12 of treatment
Number of subjects with laboratory abnormalities
Number of subjects with laboratory tests showing abnormal results
Queue A: Extended study period: Weeks 24-50; Queue B: At week 12 of treatment
Change from baseline in trough Forced Expiratory Volume in 1 second (FEV₁)
Change in FEV₁ from baseline (pulmonary function at screening) at 12 weeks of treatment
At week 12 of treatment
Secondary Outcomes (3)
Annualized rate of moderate or severe COPD acute exacerbations
Up to 48 weeks
On-treatment time to first moderate or severe exacerbation
Up to 48 weeks
Change from baseline in trough Forced Expiratory Volume in 1 second (FEV₁)
At weeks 32, 40, and 48 of treatment
Study Arms (1)
TQC3721 Suspension for Inhalation (Twice a day)
EXPERIMENTALQueue A: One TQC3721 suspension for inhalation (6mg/2ml), twice a day for 24 weeks. Queue B: One TQC3721 suspension for inhalation (6mg/2ml), twice a day for 12 weeks.
Interventions
TQC3721 suspension for inhalation is a Phosphodiesterase3/4 (PDE3/4) inhibitor.
Eligibility Criteria
You may qualify if:
- Cohort A:
- Subjects who have completed the TQC3721-III-01 clinical trial, demonstrated good medication compliance during the 24-week treatment period as required by the protocol (with no major protocol deviations related to medication compliance), and experienced no treatment-related SAEs.
- Sign the informed consent form and fully understand the trial content, procedures, and potential adverse reactions.
- Willing and able to comply with the trial arrangements and to use the nebulizer correctly.
- Subjects have no pregnancy plans from screening until at least 1 month after the last dose of the investigational drug and voluntarily adopt effective contraception measures.
- Patients with a clear clinical history and related symptoms of COPD (meeting the diagnostic criteria for COPD as outlined in the Chinese Guidelines for the Diagnosis and Management of Chronic Obstructive Pulmonary Disease (2021 Revised Edition)).
- Cohort B:
- Sign the informed consent form prior to screening and fully understand the trial content, procedures, and potential adverse reactions.
- Willing and able to comply with the trial arrangements and to use the nebulizer correctly.
- Aged between 40 and 80 years (inclusive), both male and female subjects are eligible.
- Subjects have no pregnancy plans from screening until at least 1 month after the last dose of the investigational drug and voluntarily adopt effective contraception measures.
- Patients with a clear clinical history and related symptoms of COPD prior to screening (meeting the diagnostic criteria for COPD as outlined in the Chinese Guidelines for the Diagnosis and Management of Chronic Obstructive Pulmonary Disease (2021 Revised Edition)).
- At the screening visit (V1), post-bronchodilator (salbutamol 4 puffs) lung function shows an FEV1/FVC ratio \<0.7, and 30% predicted value ≤ FEV1 \< 80% predicted value.
- A modified Medical Research Council (mMRC) dyspnea scale score of ≥1 at screening (V1).
- Subjects on single or dual bronchodilator background therapy (with or without an Inhaled Corticosteroid component) must have been on stable treatment for at least 2 weeks prior to screening.
- +2 more criteria
You may not qualify if:
- Cohort A:
- History of life-threatening chronic obstructive pulmonary disease (COPD) (e.g., prior intensive care unit admission or requiring intubation).
- Presence of other clinically significant respiratory diseases, such as alpha-1 antitrypsin deficiency, active pulmonary infection, bronchiectasis, interstitial lung disease, pulmonary arterial hypertension, or asthma.
- Any other systemic disease deemed by the investigator to be clinically significant and not adequately controlled at present.
- History or current evidence of clinically significant cardiovascular or cerebrovascular disease, specifically including:
- Myocardial infarction, unstable angina, or stroke within the past 6 months; Unstable or life-threatening arrhythmia requiring intervention within the past 3 months; New York Heart Association (NYHA) Functional Class III or IV heart failure.
- Poorly controlled hypertension despite medication (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg).
- Poorly controlled type 2 diabetes mellitus (e.g., fasting blood glucose \>10 mmol/L).
- Planned surgery before the end of the study.
- History of malignancy in any organ system within the past 5 years (except for non-metastatic basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix, with complete remission for \>5 years prior to screening).
- Clinically significant laboratory abnormalities at the screening visit (V1) as determined by the investigator, including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 × upper limit of normal (ULN), alkaline phosphatase \>2 × ULN, or total bilirubin \>1.5 × ULN.
- Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study.
- Any other condition considered by the investigator as unsuitable for participation in the study.
- Cohort B:
- History of life-threatening COPD (e.g., prior intensive care unit admission or requiring intubation).
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Chizhou People's Hospital
Chizhou, Anhui, 247000, China
Chaohu Hospital of Anhui Medical University
Hefei, Anhui, 238000, 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
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
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
Hebei PetroChina Central Hospital
Langfang, Hebei, 65000, China
People Hospital of Xingtai
Xingtai, Hebei, 054000, China
Daqing Longnan Hospital
Daqing, Heilongjiang, 163000, 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
The Central Hospital of Yongzhou
Yongzhou, Hunan, 425002, China
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 24000, 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
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
Inner Mongolia Medical University Affiliated Hospital
Hohhot, Neimenggu, 10000, 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, 261000, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200023, China
Baoji Central Hospital
Baoji, Shanxi, 721008, China
Changzhi People's Hospital
Changzhi, Shanxi, 46000, China
Yan'an University Xianyang Hospital
Xianyang, Shanxi, 712000, China
Xi'an International Medical Center Hospital
Xi’an, Shanxi, 710100, China
Yangquan coal Industry(Group) General Hospital
Yangquan, Shanxi, 45000, China
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan, 610000, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044, China
Mianyang Hospital of Traditional Chinese Medicine
Mianyang, Sichuan, 621000, 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
Jinhua municipal central hospital
Jinhua, Zhejiang, 321000, China
Dongyang People's Hospital
Jinhua, Zhejiang, 322100, 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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2026
First Posted
March 11, 2026
Study Start
April 14, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
September 28, 2026
Record last verified: 2026-03