New inhaled drug aims to tame COPD Flare-Ups in major safety trial

NCT ID NCT07464587

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests the safety of an inhaled medication called TQC3721 in 800 people with moderate to severe chronic obstructive pulmonary disease (COPD). Participants must have completed a previous related study. The main goal is to track side effects and lab abnormalities, while also checking if the drug reduces the number of serious COPD flare-ups over 48 weeks. This is not a cure; it aims to help control the disease and improve daily life.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. * 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. Exclusion Criteria: 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). * 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. * Positive viral serology: positive for human immunodeficiency virus (HIV) antibody; positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) above the lower limit of quantification of the central laboratory assay; positive for hepatitis C virus (HCV) antibody with confirmed positive HCV ribonucleic acid (RNA); or positive for \*Treponema pallidum\* antibody (TPPA). * 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.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic obstructive pulmonary disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

79 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Affiliated Hospital 2 of Nantong University

Nantong, Jiangsu, 226000, China
Affiliated Hospital of Jining Medical University

Jining, Shandong, 272029, China
Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, 637000, China
Baoji Central Hospital

Baoji, Shanxi, 721008, China
Baotou Central Hospital

Baotou, Inner Mongolia, 14000, China
Binzhou People's Hospital

Binzhou, Shandong, 256610, China
Bozhou People's Hospital

Bozhou, Anhui, 236805, China
Cangzhou Hospital of Integrated TCM- WM·HEBEI

Cangzhou, Hebei, 61013, China
Central Hospital of Dalian University of Technology

Dalian, Liaoning, 116000, China
Changzhi People's Hospital

Changzhi, Shanxi, 46000, China
Chaohu Hospital of Anhui Medical University

Hefei, Anhui, 238000, China
Chengdu Second People's Hospital

Chengdu, Sichuan, 610017, China
Chifeng Municipal Hospital

Chifeng, Inner Mongolia, 24000, China
Chizhou People's Hospital

Chizhou, Anhui, 247000, China
Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, 404000, China
Daqing Longnan Hospital

Daqing, Heilongjiang, 163000, China
Dongyang People's Hospital

Jinhua, Zhejiang, 322100, China
Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China
Fuling Hospital Affiliated to Chongqing University

Chongqing, Chongqing Municipality, 408099, China
Gansu Provincial Hospital

Lanzhou, Gansu, 730099, China
Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550000, China
Hebei Medical University Third Hospital

Shijiazhuang, Hebei, 65799, China
Hebei PetroChina Central Hospital

Langfang, Hebei, 65000, China
Heze Municipal Hospital

Heze, Shandong, 274031, China
Huizhou Central People's Hospital

Huizhou, Guangdong, 516000, China
Hunan Provincial People's Hospital

Changsha, Hunan, 410001, China
Inner Mongolia Medical University Affiliated Hospital

Hohhot, Inner Mongolia, 10000, China
Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330006, China
Jiangyin Hospital of Traditional Chinese Medicine

Wuxi, Jiangsu, 214400, China
Jiaozuo Second People's Hospital

Jiaozuo, Henan, 454001, China
Jinhua municipal central hospital

Jinhua, Zhejiang, 321000, China
Jiujiang First People's Hospital

Jiujiang, Jiangxi, 332000, China
Longgang District People's Hospital of Shenzhen

Shenzhen, Guangdong, 518000, China
Mianyang Central Hospital

Mianyang, Sichuan, 621000, China
Mianyang Hospital of Traditional Chinese Medicine

Mianyang, Sichuan, 621000, China
Nanjing Jiangning Hospital

Nanjing, Jiangsu, 21100, China
Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518000, China
Peolpe's Hospital Of Chongqing Banan District

Chongqing, Chongqing Municipality, 400054, China
People Hospital of Xingtai

Xingtai, Hebei, 054000, China
Puyang Oilfield General Hospital

Puyang, Henan, 457001, China
Qinghai Provincial People's Hospital

Xining, Qinghai, 810007, China
Qiqihar First Hospital

Qiqihar, Heilongjiang, 161005, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200023, China
Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China
Shaoxing People's Hospital

Shaoxing, Zhejiang, 312000, China
Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110021, China
Subei People's Hospital of Jiangsu province

Yangzhou, Jiangsu, 225001, China
Suining Central Hospital

Suining, Sichuan, 629099, China
Taizhou Central Hospital

Taizhou, Zhejiang, 318000, China
The Central Hospital of Yongzhou

Yongzhou, Hunan, 425002, China
The Eighth Affiliated Hospital of Southern Medical University (The First people's Hospital of Shunde )

Foshan, Guangdong, 528300, China
The Fifth People's Hospital of Wuxi

Wuxi, Jiangsu, 214001, China
The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, 610000, China
The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China
The First Affiliated Hospital of Hainan Medical University

Haikou, Hainan, 570102, China
The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315000, China
The First Affiliated Hospital of Shihezi University

Shihezi, Xinjiang, 832008, China
The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China
The First Hospital of Qinhuangdao

Qinhuangdao, Hebei, 66000, China
The First People's Hospital of Shangqiu

Shangqiu, Henan, 476100, China
The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China
The Second Hospital of Jiaxing

Jiaxing, Zhejiang, 314000, China
The Second Norman Bethune Hospital of Jilin University

Changchun, Jilin, 130000, China
The first hospital of Jilin University

Changchun, Jilin, 130000, China
Tianjin 4th Center Hospital

Tianjin, Tianjin Municipality, 300140, China
Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China
Weifang NO.2 People's Hospital

Weifang, Shandong, 261000, China
West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China
Xi'an International Medical Center Hospital

Xi’an, Shanxi, 710100, China
Xiangya Hospital of Central South University

Changsha, Hunan, 410028, China
Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China
Yan'an University Xianyang Hospital

Xianyang, Shanxi, 712000, China
Yangquan coal Industry(Group) General Hospital

Yangquan, Shanxi, 45000, China
Yantai Yuhuangding Hospital

Yantai, Shandong, 264099, China
Yichang Central People's Hospital

Yichang, Hubei, 443003, China
Yixing People's Hospital

Yixing, Jiangsu, 225000, China
Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, 363000, China

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