Chronic Obstructive Pulmonary DiseasePhase 3NCT07147946
Evaluation of the Clinical Trial of 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 76 sites in China.
Trial summary
To evaluate the efficacy of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD) 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?
- Yes, some participants may receive a placebo
- How many people
- 666 participants
- Where
- 76 sitesChina
- Study dates
- Sep 2025to Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
76 sites in 1 country. Contact the study team or a site near you to ask about taking part.
76 sites in 1 country
China76 sites
Baoji Central Hospital
Baoji, Shanxi, 721008
Kai Chen, Master, 18091698989, chenkailiyajie@163.com
Baotou Central Hospital
Baotou, Inner Mongolia, 14000
Yong Yang, Master, 13015266422, youngyong2023@163.com
Binzhou People's Hospital
Binzhou, Shandong, 256610
KaiShu Li, Doctor, 15954318626, 15954318626@163.com
Bozhou People's Hospital
Bozhou, Anhui, 236805
Yalin Jiang, Master, 15956792887, 94613793@qq.com
Cangzhou Hospital of Integrated TCM- WM·HEBEI
Cangzhou, Hebei, 61013
Lei Pan, Bachelor, 18031783607, Panlei1982@126.com
The first hospital of Jilin University
Changchun, Jilin, 130000
Liping Peng, Doctor, 13756661263, plp640317@163.com
Hunan Provincial People's Hospital
Changsha, Hunan, 410001
Nian Liu, Master, 13975188303, 19781138@qq.com
Xiangya Hospital of Central South University
Changsha, Hunan, 410028
Ruoxi He, Doctor, 18874167666, heruoxi1985@yeah.net
Changzhi People's Hospital
Changzhi, Shanxi, 46000
Xianping Zhao, Bachelor, 13453503966, ZXP13453503966@126.com
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan, 610000
Na Huang, Doctor, 15928602354, 717308813@qq.com
Chengdu Second People's Hospital
Chengdu, Sichuan, 610017
Hao Yan, Master, 18908178067, haoy6666@aliyun.com
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Weimin Li, Doctor, 028-85423998, weimin003@163.com
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 24000
Xiaohua Li, Master, 18047660682, lixiaohuaaa@aliyun.com
Chizhou People's Hospital
Chizhou, Anhui, 247000
Yuping Wei, Master, 15339668463, weiyuping@sina.com
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Li Yang, 13983769672, 315764964@qq.com
Peolpe's Hospital Of Chongqing Banan District
Chongqing, Chongqing Municipality, 400054
Tiefeng Zhang, Doctor, 13816503538, zhangtief@hotmail.com
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404000
Liangping Mao, Master, 13709436633, 13709436633@163.com
Fuling Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, 408099
Qianli Ma, Doctor, 13996030312, cqmql@163.com
Central Hospital of Dalian University of Technology
Dalian, Liaoning, 116000
Jian Xu, Doctor, 15509850880, karlinee@163.com
Daqing Longnan Hospital
Daqing, Heilongjiang, 163000
Jinli Liu, Bachelor, 18845980808, 969089802@qq.com
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
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
Xiangqi Chen, Doctor, 13365910153, chxqq2003@126.com
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550000
Xianwei Ye, Doctor, 18798619198, yxw1205@163.com
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570102
Huaping Huang, Doctor, 13138997957, 1297034257@qq.com
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Jianmin Huo, Doctor, 13804540141, 13804540141@163.com
Chaohu Hospital of Anhui Medical University
Hefei, Anhui, 238000
Fanliang Meng, Master, 13966337677, 13966337677@163.com
Heze Municipal Hospital
Heze, Shandong, 274031
Xunchao Liu, Doctor, 13184069557, lxunchao@163.com
Inner Mongolia Medical University Affiliated Hospital
Hohhot, Inner Mongolia, 10000
Lihong Wang, Master, 13848137292, 1152329174@qq.com
Huizhou Central People's Hospital
Huizhou, Guangdong, 516000
Changqing Lin, Bachelor, 13502423128, hz_linchangqing@163.com
Jiaozuo Second People's Hospital
Jiaozuo, Henan, 454001
Xinju Xu, Bachelor, 13569183612, 13569183612@163.com
The Second Hospital of Jiaxing
Jiaxing, Zhejiang, 314000
Weiqiang Mo, Bachelor, 13905733964, mm3964@sina.com
Jinhua municipal central hospital
Jinhua, Zhejiang, 321000
Dan Zhu, Bachelor, 13957962296, zhudan4252@sina.com
Dongyang People's Hospital
Jinhua, Zhejiang, 322100
Caimin Shu, Bachelor, 13566722100, Dsycm2003@163.com
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272029
Bo Jiang, Master, 15666752870, 13793771252@163.com
Jiujiang First People's Hospital
Jiujiang, Jiangxi, 332000
Jun Li, Bachelor, 13870267661, lijun7661@126.com
Hebei PetroChina Central Hospital
Langfang, Hebei, 65000
Zheng Liu, Master, 186 3261 9559, keaiduo68@163.com
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Xiaoju Liu, Doctor, 13919360884, Liuxiaoju835@126.co
Gansu Provincial Hospital
Lanzhou, Gansu, 730099
Weidong Hu, Bachelor, 13519311855, weidong-618@163.com
Linxia Fan, Master, 13609311774, fanlinxia6@163.com
Mianyang Central Hospital
Mianyang, Sichuan, 621000
Weiguo Xu, Doctor, 13981102503, xwg522630@126.com
Mianyang Hospital of Traditional Chinese Medicine
Mianyang, Sichuan, 621000
Ye Gao, Doctor, 13881138014, gaoye1001@126.com
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
Zuke Xiao, Bachelor, 13970010036, Xiaozuke@126.com
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Wei Zuo, Master, 15879098337, 11545394@qq.com
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000
Li JiangJiang, Doctor, 18281718585, lanqilily@163.com
Nanjing Jiangning Hospital
Nanjing, Jiangsu, 21100
Xiuwei Zhang, Doctor, 17705191598, zhangxiuweiywy@126.com
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000
Chao Cao, Master, 18258796161, caocdoctor@163.com
Puyang Oilfield General Hospital
Puyang, Henan, 457001
Faming Yu, Bachelor, 13700802698, mingfayu@126.com
The First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 66000
Hua Qiao, Master, 13780358298, qh1202@163.com
Qiqihar First Hospital
Qiqihar, Heilongjiang, 161005
Jian Ding, Master, 15645231111, 252518789@qq.com
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200023
Ranran Dai, Doctor, 13918139360, drr11154@rjh.com.cn
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Min Zhang, Doctor, 13482345145, maggie_zhangmin@163.com
The First People's Hospital of Shangqiu
Shangqiu, Henan, 476100
Chunling Zhang, Master, 13781626918, chunlingz@yeah.net
Shaoxing People's Hospital
Shaoxing, Zhejiang, 312000
Jian Sun, Doctor, 13588508420, 2002sunjian@163.com
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110021
Rui Zheng, Master, 18940002266, zhengr@sj-hospital.org
Longgang District People's Hospital of Shenzhen
Shenzhen, Guangdong, 518000
Liang Zhou, Doctor, 18938901742, zhouliang1115@163.com
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518000
Ruilin Sun, Doctor, 13825167802, sunruilin213@126.com
The First Affiliated Hospital of Shihezi University
Shihezi, Xinjiang, 832008
Dong Liu, Master, 13779702431, 13779702431@163.com
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, 65799
Yunxia Zhao, Doctor, 18533112506, zhaoyunxia990303@163.com
Suining Central Hospital
Suining, Sichuan, 629099
Rong Qiu, Doctor, 18008258545, 443182163@qq.com
Taizhou Central Hospital
Taizhou, Zhejiang, 318000
Junfei Zhu, Master, 13968600802, zhujf@tzzxyy.com
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Jie Cao, Master, 13132088076, tjcaojie@sina.com
Tianjin 4th Center Hospital
Tianjin, Tianjin Municipality, 300140
Jingchun He, Master, 13820132084, jingjunhe98@163.com
Weifang NO.2 People's Hospital
Weifang, Shandong, 261041
Guoru Yang, Bachelor, 13963601993, yangguoru@163.com
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Liqin Wu, Master, 13587861043, happy-qin@163.com
The Fifth People's Hospital of Wuxi
Wuxi, Jiangsu, 214001
Feng Zhu, Doctor, 13914135026, 181515688@qq.com
Jiangyin Hospital of Traditional Chinese Medicine
Wuxi, Jiangsu, 214400
Xiaodong Hu, Bachelor, 17768318018, 30223273@qq.com
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710100
Changgui Wu, Doctor, 13892899669, wcg196211@163.com
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, 712000
Jianhou Jia, Bachelor, 13892007197, jjh20@126.com
Qinghai Provincial People's Hospital
Xining, Qinghai, 810007
Yajun Tuo, Bachelor, 13897583488, 1134491856@qq.com
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009
Yanmin Wu, Master, 18952170625, wymin666@163.com
Yangquan coal Industry(Group) General Hospital
Yangquan, Shanxi, 45000
Ruibin Guo, Bachelor, 13935324120, grb8888@126.com
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, 225001
Lingfeng Min, Doctor, 18051061783, minlingfeng@126.com
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099
Shenchun Zhou, Master, 18660515179, ytbqjwhx@sina.com
Yichang Central People's Hospital
Yichang, Hubei, 443003
Fanjun Zeng, Master, 13997672619, 438864941@qq.com
Yixing People's Hospital
Yixing, Jiangsu, 225000
Xiuqin Ma, Master, 13815117833, staff799@yxph.com
Jianzhong Jiang, Bachelor, 15906156662, staff290@yxph.com
The Central Hospital of Yongzhou
Yongzhou, Hunan, 425002
Ni Zhang, Bachelor, 15200973322, 1335614905@qq.com
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, 363000
Li Lin, Bachelor, 13605080222, linlid222@163.com
About this study
Official title: 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
To evaluate the efficacy of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- TQC3721 Suspension for inhalation, Placebo of 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
Placebo of TQC3721 Suspension for InhalationDrug
Placebo without drug substance
| Study group | Role | What they receive |
|---|---|---|
| TQC3721 Suspension for Inhalation | Experimental | Inhalation of TQC3721 suspension (6mg/2ml), one unit dose twice daily for 24 weeks Receives: Drug: TQC3721 Suspension for inhalation |
| Placebo of TQC3721 Suspension for Inhalation | Placebo comparator | Inhalation of TQC3721 placebo, one unit dose twice daily for 24 weeks Receives: Drug: Placebo of TQC3721 Suspension for Inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 weeks after treatment
Secondary outcomes (15)
Changes in peak FEV1 value
Changes from baseline in peak FEV1 within 4 hours after morning dosing at Weeks 6, 12, and 24 of treatment.
Measured: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Changes in trough FEV1 values
Changes from baseline in morning trough FEV1 at Weeks 6, 12, and 24 of treatment.
Measured: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Average FEV1 AUC 0-4h
Change from baseline in the average FEV1 AUC 0-4h within 4 hours after morning dosing at 6, 12, and 24 weeks of treatment.
Measured: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
St. George's Respiratory Questionnaire
Changes in St. George's Respiratory Questionnaire (SGRQ) total scores from baseline at 6, 12, and 24 weeks of treatment.
Measured: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Chronic Obstructive Pulmonary Disease Assessment Test
Self-assessment for Patients with COPD：Numbers 0 to 5 indicate the severity (with 0 being the mildest and 5 being the most severe).
Measured: At 6 weeks, 12 weeks, and 24 weeks of treatment
Average FEV1 AUC (6-12h)
Change from baseline in mean FEV₁ AUC (6-12 h) at Week 12 following dosing.
Measured: Baseline to 12 weeks after treatment
Annual rate of acute exacerbation of COPD
The annualized rate of acute exacerbation of moderate/severe COPD after 24 weeks of treatment.
Measured: Baseline to 24 weeks after treatment
Time of first acute exacerbation of moderate/severe COPD
The time of the first acute exacerbation of moderate/severe COPD within 24 weeks of treatment.
Measured: Baseline to 24 weeks after treatment
Adverse event (AE)
The number of participants with AEs, serious dverse event (SAEs), drug-related AEs, and abnormal lab results.
Measured: D-28 to within 25 weeks of treatment
Assessment of respiratory symptoms in COPD
Change from baseline in weekly mean Evaluating Respiratory Symptoms in COPD total score
Measured: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Transition Dyspnea Index (TDI) score
Change in Transition Dyspnea Index (TDI) score relative to Baseline Dyspnea Index (BDI) score
Measured: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score
Change in Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score from baseline
Measured: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Change from baseline in rescue medication use
Changes from baseline in rescue medication use during treatment at Weeks 6, 12, and 24 versus the placebo group
Measured: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment.
Interleukin-6 (IL-6), Interleukin-8 (IL-8), and C-reactive protein (CRP) at Week 12 and Week 24
IL-6, IL-8, and C-reactive protein (CRP) at Week 12 and Week 24. The elevated serum C-reactive protein (CRP) levels in patients with chronic obstructive pulmonary disease (COPD) are primarily associated with pulmonary inflammatory responses.
Measured: At Week 12 and Week 24
Plasma drug peak concentration
Perform Pharmacokinetics (PK) analysis of TQC3721 blood drug concentration data at baseline, week 6, and week 12 to evaluate the PK characteristics of TQC3721 in COPD patients.
Measured: Day 1: 0.5 hour after-dose, Week 6: 1 hour pre-dose, 0.5 hour after-dose; Week 12: 1 hour pre-dose, 0.5 hour after-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 666 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
- NCT07147946
- Sponsor's protocol ID
- TQC3721-III-01
- Status last verified
- Jun 2025
- First submitted
- 22 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07147946
- Acronym / sponsor ID
- TQC3721-III-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 666 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQC3721 Suspension for Inhalation | Experimental | Drug: TQC3721 Suspension for inhalationInhalation of TQC3721 suspension (6mg/2ml), one unit dose twice daily for 24 weeks |
| Placebo of TQC3721 Suspension for Inhalation | Placebo comparator | Drug: Placebo of TQC3721 Suspension for InhalationInhalation of TQC3721 placebo, one unit dose twice daily for 24 weeks |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQC3721 Suspension for inhalationTQC3721 suspension for inhalation is a Phosphodiesterase3/4 (PDE3/4) inhibitor | Drug | TQC3721 Suspension for Inhalation |
| Placebo of TQC3721 Suspension for InhalationPlacebo without drug substance | Drug | Placebo of TQC3721 Suspension for Inhalation |
Primary outcome
Mean change in the area under the curve (AUC) of Forced Expiratory Volume in 1 second (FEV1)
Time frame: Baseline to 12 weeks after treatment
Change from baseline in mean FEV1 AUC over 0-12 hours after 12 weeks of treatment.
15 secondary outcomes
Changes in peak FEV1 value
Time frame: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Changes in trough FEV1 values
Time frame: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Average FEV1 AUC 0-4h
Time frame: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
St. George's Respiratory Questionnaire
Time frame: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Chronic Obstructive Pulmonary Disease Assessment Test
Time frame: At 6 weeks, 12 weeks, and 24 weeks of treatment
Average FEV1 AUC (6-12h)
Time frame: Baseline to 12 weeks after treatment
Annual rate of acute exacerbation of COPD
Time frame: Baseline to 24 weeks after treatment
Time of first acute exacerbation of moderate/severe COPD
Time frame: Baseline to 24 weeks after treatment
Adverse event (AE)
Time frame: D-28 to within 25 weeks of treatment
Assessment of respiratory symptoms in COPD
Time frame: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Transition Dyspnea Index (TDI) score
Time frame: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score
Time frame: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment
Change from baseline in rescue medication use
Time frame: Baseline to 6 weeks, 12 weeks, 24 weeks after treatment.
Interleukin-6 (IL-6), Interleukin-8 (IL-8), and C-reactive protein (CRP) at Week 12 and Week 24
Time frame: At Week 12 and Week 24
Plasma drug peak concentration
Time frame: Day 1: 0.5 hour after-dose, Week 6: 1 hour pre-dose, 0.5 hour after-dose; Week 12: 1 hour pre-dose, 0.5 hour after-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
76 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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 76 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weimin Li, Doctor (028-85423998, weimin003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in the area under the curve (AUC) of Forced Expiratory Volume in 1 second (FEV1) (time frame: Baseline to 12 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.