Status:
COMPLETED
A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy and safety of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD)
Eligibility Criteria
Inclusion
- Sign informed consent before the test and fully understand the test content, process and possible adverse reactions.
- Male and female subjects aged 40 to 80 years old (including the cut-off value).
- Body mass index (BMI) in the range of 18-30kg/m2 (including the critical value)
- Subjects have no pregnancy plan and voluntarily use effective contraception for at least 1 month from screening to the last use of the study drug.
- Diagnosed as a COPD patient according to the The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 criteria.
- Able to conduct acceptable and reproducible lung function tests.
- COPD clinical stability within the 4 weeks prior to screening visit (V1 visit) and between V1 visit and V2 visit.
- Smoking history ≥ 10 pack years.
Exclusion
- History of life-threatening COPD, including admission to the intensive care unit and/or the need for intubation.
- Screening for COPD acute exacerbations that require systemic hormone therapy prior to the visit.
- Screening for hospitalization history due to COPD within the first 6 months.
- Use antibiotics for respiratory tract infections within 6 weeks prior to screening or randomization visit.
- 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.
- Pulmonary rehabilitation treatment.
- Previously received TQC3721 treatment.
- Patients who received immunotherapy within the first 4 weeks of the screening period.
- The patient has a history of diseases that are currently beyond their control.
- History or current evidence of cardiovascular disease with clinical significance.
- History of cured or untreated malignant tumors in any organ or system within the past 5 years.
- Screening for clinically significant safety laboratory test outliers determined by the researcher during the visit.
- Those who require oxygen therapy or intermittent oxygen therapy.
- Receive attenuated live vaccine within 28 days prior to randomization, inactivated vaccine within 7 days, or study.
- Planned vaccine recipients during the period.
- Individuals who have participated in any drug or medical device clinical trials prior to screening.
- Researchers believe that there are other situations that are not suitable for participation in the study.
Key Trial Info
Start Date :
September 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06527144
Start Date
September 14 2024
End Date
March 6 2025
Last Update
April 11 2025
Active Locations (28)
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1
Fu Yang People'S Hospital
Fuyang, Anhui, China, 236000
2
ChongQing University Fuling Hospital
Chongqing, Chongqing Municipality, China, 400000
3
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, China, 361021
4
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000