Chronic Obstructive Pulmonary DiseasePhase 3NCT07464587
Evaluation of the Inhaled TQC3721 Suspension in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease
A Phase 3 study testing TQC3721 Suspension for Inhalation in people with Chronic Obstructive Pulmonary Disease, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 54 sites in China.
Trial summary
To evaluate the safety of inhaled TQC3721 Suspension in patients with moderate to severe Chronic Obstructive Pulmonary Disease Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- TQC3721 Suspension for Inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 54 sitesChina
- Study dates
- 14 Apr 2026to Nov 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)).
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- 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.
- Clinically stable COPD (no moderate or severe COPD exacerbations) within 4 weeks prior to the screening visit (Visit V1).
- Smoking history of ≥10 pack-years (pack-years: packs per day * years of smoking, e.g., 1 pack of 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years) OR a history of exposure to biomass fuels.
Who cannot join
- 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.
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- 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).
- Experienced a COPD exacerbation requiring systemic corticosteroids within 3 months prior to the screening visit (V1).
- One or more hospitalizations due to COPD exacerbation or pneumonia within 3 months prior to screening.
- Presence of other clinically significant respiratory diseases, as specified in Criterion A.2.
- Chest computed tomography (CT) scan showing clinically significant abnormalities not attributable to COPD and judged by the investigator to potentially affect trial evaluation or subject safety.
- Use of oral theophylline or its derivatives for COPD treatment within 1 week prior to the screening visit (V1).
- Prior treatment with TQC3721.
- 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, as specified in Criteria A.4.
- Poorly controlled hypertension, as specified in Criterion A.5.
- Poorly controlled type 2 diabetes mellitus, as specified in Criterion A.6.
- Major surgery (requiring general anesthesia) within 8 weeks prior to the screening visit (V1) with incomplete recovery, or planned surgery before the end of the study.
- Clinically significant laboratory abnormalities at screening, as specified in Criterion A.9.
- Requirement for long-term daily oxygen therapy (defined as cumulative use >12 hours per day).
- Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study.
- Participation in any other investigational drug or medical device clinical trial within 4 weeks prior to screening, or within 5 half-lives of the previous investigational agent (whichever is longer).
- Any other condition considered by the investigator as unsuitable for participation in the study.
Trial locations and contacts
54 sites in 1 country. Contact the study team or a site near you to ask about taking part.
54 sites in 1 country
China54 sites, 54 recruiting
- Recruiting
Baoji Central Hospital
Baoji, Shanxi, 721008
Kai Chen, Master, 18091698989, chenkailiyajie@163.com
- Recruiting
Binzhou People's Hospital
Binzhou, Shandong, 256610
KaiShu Li, Doctor, 15954318626, 15954318626@163.com
- Recruiting
The first hospital of Jilin University
Changchun, Jilin, 130000
Liping Peng, Doctor, 13756661263, plp640317@163.com
- Recruiting
Hunan Provincial People's Hospital
Changsha, Hunan, 410001
Nian Liu, Master, 13975188303, 19781138@qq.com
- Recruiting
Changzhi People's Hospital
Changzhi, Shanxi, 46000
Xianping Zhao, Bachelor, 13453503966, ZXP13453503966@126.com
- Recruiting
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan, 610000
Na Huang, Doctor, 15928602354, 717308813@qq.com
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Weimin Li, Doctor, 028-85423998, weimin003@163.com
- Recruiting
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 24000
Xiaohua Li, Master, 18047660682, lixiaohuaaa@aliyun.com
- Recruiting
Chizhou People's Hospital
Chizhou, Anhui, 247000
Yuping Wei, Master, 15339668463, weiyuping@sina.com
- Recruiting
Peolpe's Hospital Of Chongqing Banan District
Chongqing, Chongqing Municipality, 400054
Tiefeng Zhang, Doctor, 13816503538, zhangtief@hotmail.com
- Recruiting
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404000
Liangping Mao, Master, 13709436633, 13709436633@163.com
- Recruiting
Fuling Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, 408099
Qianli Ma, Doctor, 13996030312, cqmql@163.com
- Recruiting
Central Hospital of Dalian University of Technology
Dalian, Liaoning, 116000
Jian Xu, Doctor, 15509850880, karlinee@163.com
- Recruiting
Daqing Longnan Hospital
Daqing, Heilongjiang, 163000
Jinli Liu, Bachelor, 18845980808, 969089802@qq.com
- Recruiting
The Eighth Affiliated Hospital of Southern Medical University (The First people's Hospital of Shunde )
Foshan, Guangdong, 528300
Yanhua Lv, Doctor, 18923332273, lyhshunde@163.com
- Recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550000
Xianwei Ye, Doctor, 18798619198, yxw1205@163.com
- Recruiting
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102
Huaping Huang, Doctor, 13138997957, 1297034257@qq.com
- Recruiting
Chaohu Hospital of Anhui Medical University
Hefei, Anhui, 238000
Fanliang Meng, Master, 13966337677, 13966337677@163.com
- Recruiting
Heze Municipal Hospital
Heze, Shandong, 274031
Xunchao Liu, Doctor, 13184069557, lxunchao@163.com
- Recruiting
Inner Mongolia Medical University Affiliated Hospital
Hohhot, Neimenggu, 10000
Lihong Wang, Master, 13848137292, 1152329174@qq.com
- Recruiting
Jiaozuo Second People's Hospital
Jiaozuo, Henan, 454001
Xinju Xu, Bachelor, 13569183612, 13569183612@163.com
- Recruiting
Jinhua municipal central hospital
Jinhua, Zhejiang, 321000
Dan Zhu, Bachelor, 13957962296, zhudan4252@sina.com
- Recruiting
Dongyang People's Hospital
Jinhua, Zhejiang, 322100
Caimin Shu, Bachelor, 13566722100, Dsycm2003@163.com
- Recruiting
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272029
Bo Jiang, Master, 15666752870, 13793771252@163.com
- Recruiting
Hebei PetroChina Central Hospital
Langfang, Hebei, 65000
Zheng Liu, Master, 186 3261 9559, keaiduo68@163.com
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Xiaoju Liu, Doctor, 13919360884, Liuxiaoju835@126.com
- Recruiting
Gansu Provincial Hospital
Lanzhou, Gansu, 730099
Weidong Hu, Bachelor, 13519311855, weidong-618@163.com
Linxia Fan, Master, 13609311774, fanlinxia6@163.com
- Recruiting
Mianyang Hospital of Traditional Chinese Medicine
Mianyang, Sichuan, 621000
Ye Gao, Doctor, 13881138014, gaoye1001@126.com
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
Zuke Xiao, Bachelor, 13970010036, Xiaozuke@126.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Wei Zuo, Master, 15879098337, 11545394@qq.com
- Recruiting
Puyang Oilfield General Hospital
Puyang, Henan, 457001
Faming Yu, Bachelor, 13700802698, mingfayu@126.com
- Recruiting
Qiqihar First Hospital
Qiqihar, Heilongjiang, 161005
Jian Ding, Master, 15645231111, 252518789@qq.com
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200023
Ranran Dai, Doctor, 13918139360, drr11154@rjh.com.cn
- Recruiting
The First People's Hospital of Shangqiu
Shangqiu, Henan, 476100
Chunling Zhang, Master, 13781626918, chunlingz@yeah.net
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110021
Rui Zheng, Master, 18940002266, zhengr@sj-hospital.org
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518000
Zhongdong lv, Doctor, 13825167802, sunruilin213@126.com
- Recruiting
The First Affiliated Hospital of Shihezi University
Shihezi, Xinjiang, 832008
Dong Liu, Master, 13779702431, 13779702431@163.com
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Jie Cao, Master, 13132088076, tjcaojie@sina.com
- Recruiting
Tianjin 4th Center Hospital
Tianjin, Tianjin Municipality, 300140
Jingchun He, Master, 13820132084, jingjunhe98@163.com
- Recruiting
Weifang NO.2 People's Hospital
Weifang, Shandong, 261000
Guoru Yang, Bachelor, 13963601993, yangguoru@163.com
- Recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Liqin Wu, Master, 13587861043, happy-qin@163.com
- Recruiting
The Fifth People's Hospital of Wuxi
Wuxi, Jiangsu, 214001
Feng Zhu, Doctor, 13914135026, 181515688@qq.com
- Recruiting
Jiangyin Hospital of Traditional Chinese Medicine
Wuxi, Jiangsu, 214400
Xiaodong Hu, Bachelor, 17768318018, 30223273@qq.com
- Recruiting
Xi'an International Medical Center Hospital
Xi’an, Shanxi, 710100
Changgui Wu, Doctor, 13892899669, wcg196211@163.com
- Recruiting
Yan'an University Xianyang Hospital
Xianyang, Shanxi, 712000
Jianhou Jia, Bachelor, 13892007197, jjh20@126.com
- Recruiting
People Hospital of Xingtai
Xingtai, Hebei, 054000
Zhiguo Gao, Master, 13482950466, gaozhiguohao@126.com
- Not yet recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009
Yanmin Wu, Master, 18952170625, wymin666@163.com
- Recruiting
Yangquan coal Industry(Group) General Hospital
Yangquan, Shanxi, 45000
Ruibin Guo, Bachelor, 13935324120, grb8888@126.com
- Recruiting
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, 225001
Lingfeng Min, Doctor, 18051061783, minlingfeng@126.com
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099
Shenchun Zhou, Master, 18660515179, ytbqjwhx@sina.com
- Recruiting
Yichang Central People's Hospital
Yichang, Hubei, 443003
Fanjun Zeng, Master, 13997672619, 438864941@qq.com
- Recruiting
Yixing People's Hospital
Yixing, Jiangsu, 225000
Xiuqin Ma, Master, 13815117833, staff799@yxph.com
Jianzhong Jiang, Bachelor, 15906156662, staff290@yxph.com
- Recruiting
The Central Hospital of Yongzhou
Yongzhou, Hunan, 425002
Ni Zhang, Bachelor, 15200973322, 1335614905@qq.com
- Recruiting
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, 363000
Li Lin, Bachelor, 13605080222, linlid222@163.com
About this study
Official title: Evaluation of Safety Profile in a Cohort Study of Inhaled TQC3721 Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
To evaluate the safety of inhaled TQC3721 Suspension in patients with moderate to severe Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- TQC3721 Suspension for Inhalation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQC3721 Suspension for InhalationDrug
TQC3721 suspension for inhalation is a Phosphodiesterase3/4 (PDE3/4) inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| TQC3721 Suspension for Inhalation (Twice a day) | Experimental | Queue 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. Receives: Drug: TQC3721 Suspension for Inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Measured: 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
Measured: 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
Measured: At week 12 of treatment
Secondary outcomes (3)
Annualized rate of moderate or severe COPD acute exacerbations
Annualized rate of moderate or severe Obstructive Chronic Pulmonary Disease (COPD) acute exacerbations over 48 weeks of treatment (compared according to the treatment groups in the TQC3721-III-01 study).
Measured: Up to 48 weeks
On-treatment time to first moderate or severe exacerbation
Time to first moderate or severe COPD exacerbation over the 48-week treatment period (To be compared according to the randomized treatment groups assigned in the TQC3721-III-01 study).
Measured: Up to 48 weeks
Change from baseline in trough Forced Expiratory Volume in 1 second (FEV₁)
Analysis of change from baseline in trough FEV₁ at weeks 32, 40, and 48 of treatment (Baseline is defined as the corresponding value from the TQC3721-III-01 study; comparisons will be performed according to the randomized treatment groups assigned in that study).
Measured: At weeks 32, 40, and 48 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start14 Apr 2026
- Primary completionFeb 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464587
- Sponsor's protocol ID
- TQC3721-III-02
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No