TQC3721 Suspension for Inhalation: TQC3721 suspension for inhalation is a Phosphodiesterase3/4 (PDE3/4) inhibitor.
Study summary
To evaluate the safety of inhaled TQC3721 Suspension in patients with moderate to severe Chronic Obstructive Pulmonary Disease
Eligibility
Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Adverse event rate — 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).
Number of subjects with laboratory abnormalities — Queue A: Extended study period: Weeks 24-50; Queue B: At week 12 of treatment Number of subjects with laboratory tests showing abnormal results
Trial sites (79)
Facility
City
Region
Status
Bozhou People's Hospital
Bozhou
Anhui
Chizhou People's Hospital
Chizhou
Anhui
Chaohu Hospital of Anhui Medical University
Hefei
Anhui
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Chongqing Municipality
Peolpe's Hospital Of Chongqing Banan District
Chongqing
Chongqing Municipality
Chongqing University Three Gorges Hospital
Chongqing
Chongqing Municipality
Fuling Hospital Affiliated to Chongqing University
Chongqing
Chongqing Municipality
Fujian Medical University Union Hospital
Fuzhou
Fujian
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou
Fujian
The First Hospital of Lanzhou University
Lanzhou
Gansu
Gansu Provincial Hospital
Lanzhou
Gansu
The Eighth Affiliated Hospital of Southern Medical University (The First people's Hospital of Shunde )
Foshan
Guangdong
Huizhou Central People's Hospital
Huizhou
Guangdong
Longgang District People's Hospital of Shenzhen
Shenzhen
Guangdong
Peking University Shenzhen Hospital
Shenzhen
Guangdong
Guizhou Provincial People's Hospital
Guiyang
Guizhou
The First Affiliated Hospital of Hainan Medical University
Haikou
Hainan
Cangzhou Hospital of Integrated TCM- WM·HEBEI
Cangzhou
Hebei
Hebei PetroChina Central Hospital
Langfang
Hebei
The First Hospital of Qinhuangdao
Qinhuangdao
Hebei
Hebei Medical University Third Hospital
Shijiazhuang
Hebei
People Hospital of Xingtai
Xingtai
Hebei
Daqing Longnan Hospital
Daqing
Heilongjiang
The First Affiliated Hospital of Harbin Medical University
Harbin
Heilongjiang
Qiqihar First Hospital
Qiqihar
Heilongjiang
Jiaozuo Second People's Hospital
Jiaozuo
Henan
Puyang Oilfield General Hospital
Puyang
Henan
The First People's Hospital of Shangqiu
Shangqiu
Henan
Yichang Central People's Hospital
Yichang
Hubei
Hunan Provincial People's Hospital
Changsha
Hunan
Xiangya Hospital of Central South University
Changsha
Hunan
The Central Hospital of Yongzhou
Yongzhou
Hunan
Baotou Central Hospital
Baotou
Inner Mongolia
Chifeng Municipal Hospital
Chifeng
Inner Mongolia
Inner Mongolia Medical University Affiliated Hospital
Hohhot
Inner Mongolia
Nanjing Jiangning Hospital
Nanjing
Jiangsu
Affiliated Hospital 2 of Nantong University
Nantong
Jiangsu
The Fifth People's Hospital of Wuxi
Wuxi
Jiangsu
Jiangyin Hospital of Traditional Chinese Medicine
Wuxi
Jiangsu
Xuzhou Central Hospital
Xuzhou
Jiangsu
+ 39 more sites — see the full list on the official registry below.
More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.