Evaluation of the Inhaled TQC3721 Suspension in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease

March 7, 2026 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Bozhou, Anhui, China, 236805
        • Bozhou People's Hospital
        • Contact:
      • Chizhou, Anhui, China, 247000
        • Chizhou People's Hospital
        • Contact:
      • Hefei, Anhui, China, 238000
        • Chaohu Hospital of Anhui Medical University
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 404000
        • Chongqing University Three Gorges Hospital
        • Contact:
      • Chongqing, Chongqing Municipality, China, 400010
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
      • Chongqing, Chongqing Municipality, China, 400054
        • Peolpe's Hospital Of Chongqing Banan District
        • Contact:
      • Chongqing, Chongqing Municipality, China, 408099
        • Fuling Hospital Affiliated to Chongqing University
        • Contact:
          • Qianli Ma, Doctor
          • Phone Number: 13996030312
          • Email: cqmql@163.com
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Fujian Medical University Union Hospital
        • Contact:
      • Zhangzhou, Fujian, China, 363000
        • Zhangzhou Municipal Hospital of Fujian Province
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • The First Hospital of Lanzhou University
        • Contact:
      • Lanzhou, Gansu, China, 730099
        • Gansu Provincial Hospital
        • Contact:
        • Contact:
    • Guangdong
      • Foshan, Guangdong, China, 528300
        • The Eighth Affiliated Hospital of Southern Medical University (The First people's Hospital of Shunde )
        • Contact:
      • Huizhou, Guangdong, China, 516000
        • Huizhou Central People's Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518000
        • Peking University Shenzhen Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518000
        • Longgang District People's Hospital of Shenzhen
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • Guizhou Provincial People's Hospital
        • Contact:
    • Hainan
      • Haikou, Hainan, China, 570102
        • The First Affiliated Hospital of Hainan Medical University
        • Contact:
    • Hebei
      • Cangzhou, Hebei, China, 61013
        • Cangzhou Hospital of Integrated TCM- WM·HEBEI
        • Contact:
      • Langfang, Hebei, China, 65000
        • Hebei PetroChina Central Hospital
        • Contact:
      • Qinhuangdao, Hebei, China, 66000
        • The First Hospital of Qinhuangdao
        • Contact:
      • Shijiazhuang, Hebei, China, 65799
        • Hebei medical university third hospital
        • Contact:
      • Xingtai, Hebei, China, 054000
        • People Hospital of Xingtai
        • Contact:
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163000
        • Daqing Longnan Hospital
        • Contact:
      • Harbin, Heilongjiang, China, 150001
        • The First Affiliated Hospital of Harbin Medical University
        • Contact:
      • Qiqihar, Heilongjiang, China, 161005
        • Qiqihar First Hospital
        • Contact:
    • Henan
      • Jiaozuo, Henan, China, 454001
        • Jiaozuo Second People's Hospital
        • Contact:
      • Puyang, Henan, China, 457001
        • Puyang Oilfield General Hospital
        • Contact:
      • Shangqiu, Henan, China, 476100
        • The First People's Hospital of Shangqiu
        • Contact:
    • Hubei
      • Yichang, Hubei, China, 443003
        • Yichang Central People's Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410001
        • Hunan Provincial People's Hospital
        • Contact:
      • Changsha, Hunan, China, 410028
        • Xiangya Hospital of Central South University
        • Contact:
      • Yongzhou, Hunan, China, 425002
        • The Central Hospital of Yongzhou
        • Contact:
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 14000
        • Baotou Central Hospital
        • Contact:
      • Chifeng, Inner Mongolia, China, 24000
        • Chifeng Municipal Hospital
      • Hohhot, Inner Mongolia, China, 10000
        • Inner Mongolia Medical University Affiliated Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 21100
        • Nanjing Jiangning Hospital
        • Contact:
      • Nantong, Jiangsu, China, 226000
        • Affiliated Hospital 2 of Nantong University
        • Contact:
      • Wuxi, Jiangsu, China, 214001
        • The Fifth People's Hospital of Wuxi
        • Contact:
      • Wuxi, Jiangsu, China, 214400
        • Jiangyin Hospital of Traditional Chinese Medicine
        • Contact:
      • Xuzhou, Jiangsu, China, 221009
        • Xuzhou Central Hospital
        • Contact:
      • Yangzhou, Jiangsu, China, 225001
        • Subei People's Hospital of Jiangsu province
        • Contact:
      • Yixing, Jiangsu, China, 225000
        • Yixing People'S Hospital
        • Contact:
        • Contact:
    • Jiangxi
      • Jiujiang, Jiangxi, China, 332000
        • Jiujiang First People's Hospital
        • Contact:
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial People's Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130000
        • The First Hospital of Jilin University
        • Contact:
      • Changchun, Jilin, China, 130000
        • The Second Norman Bethune Hospital of Jilin University
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116000
        • Central Hospital of Dalian University of Technology
        • Contact:
      • Shenyang, Liaoning, China, 110021
        • Shengjing Hospital Of China Medical University
    • Qinghai
      • Xining, Qinghai, China, 810007
        • Qinghai provincial people's hospital
        • Contact:
    • Shandong
      • Binzhou, Shandong, China, 256610
        • Binzhou People's Hospital
        • Contact:
      • Heze, Shandong, China, 274031
        • Heze Municipal Hospital
        • Contact:
      • Jining, Shandong, China, 272029
        • Affiliated Hospital of Jining Medical University
        • Contact:
      • Weifang, Shandong, China, 261000
        • Weifang NO.2 People's Hospital
        • Contact:
      • Yantai, Shandong, China, 264099
        • Yantai Yuhuangding Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200080
      • Shanghai, Shanghai Municipality, China, 200023
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
    • Shanxi
      • Baoji, Shanxi, China, 721008
      • Changzhi, Shanxi, China, 46000
        • Changzhi People's Hospital
        • Contact:
      • Xianyang, Shanxi, China, 712000
        • Yan'an University Xianyang Hospital
        • Contact:
          • Jianhou Jia, Bachelor
          • Phone Number: 13892007197
          • Email: jjh20@126.com
      • Xi’an, Shanxi, China, 710100
        • Xi'an International Medical Center Hospital
        • Contact:
      • Yangquan, Shanxi, China, 45000
        • Yangquan coal Industry(Group) General Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610044
        • West China Hospital of Sichuan University
        • Contact:
      • Chengdu, Sichuan, China, 610017
        • Chengdu Second People's Hospital
      • Chengdu, Sichuan, China, 610000
        • The First Affiliated Hospital of Chengdu Medical College
        • Contact:
      • Mianyang, Sichuan, China, 621000
        • Mianyang Central Hospital
        • Contact:
      • Mianyang, Sichuan, China, 621000
        • Mianyang Hospital of Traditional Chinese Medicine
        • Contact:
      • Nanchong, Sichuan, China, 637000
        • Affiliated Hospital of North Sichuan Medical College
        • Contact:
      • Suining, Sichuan, China, 629099
        • Suining Central Hospital
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052
        • Tianjin Medical University General Hospital
        • Contact:
      • Tianjin, Tianjin Municipality, China, 300140
        • Tianjin 4th Center Hospital
        • Contact:
    • Xinjiang
      • Shihezi, Xinjiang, China, 832008
        • The First Affiliated Hospital of Shihezi University
        • Contact:
    • Zhejiang
      • Jiaxing, Zhejiang, China, 314000
        • The Second Hospital of Jiaxing
        • Contact:
      • Jinhua, Zhejiang, China, 321000
        • Jinhua municipal central hospital
        • Contact:
      • Jinhua, Zhejiang, China, 322100
        • Dongyang People's Hospital
        • Contact:
      • Ningbo, Zhejiang, China, 315000
        • The First Affiliated Hospital of Ningbo University
        • Contact:
      • Shaoxing, Zhejiang, China, 312000
        • Shaoxing People's Hospital
        • Contact:
      • Taizhou, Zhejiang, China, 318000
        • Taizhou Central Hospital
        • Contact:
      • Wenzhou, Zhejiang, China, 325000
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQC3721 Suspension for Inhalation (Twice a day)

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.
Drug: TQC3721 Suspension for Inhalation
TQC3721 suspension for inhalation is a Phosphodiesterase3/4 (PDE3/4) inhibitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event rate
Time Frame: Queue A: Extended study period: Weeks 24-50; Queue B: At week 12 of treatment
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
Time Frame: Queue A: Extended study period: Weeks 24-50; Queue B: At week 12 of treatment
Number of subjects with laboratory tests showing abnormal results
Queue A: Extended study period: Weeks 24-50; Queue B: At week 12 of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized rate of moderate or severe COPD acute exacerbations
Time Frame: Up to 48 weeks
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).
Up to 48 weeks
On-treatment time to first moderate or severe exacerbation
Time Frame: Up to 48 weeks
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).
Up to 48 weeks
Change from baseline in trough Forced Expiratory Volume in 1 second (FEV₁)
Time Frame: At weeks 32, 40, and 48 of treatment
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).
At weeks 32, 40, and 48 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 7, 2026

First Submitted That Met QC Criteria

March 7, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQC3721-III-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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