A Clinical Trial of TQC3721 Suspension for Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial of the Efficacy and Safety of Inhaled TQC3721 Suspension in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
240
1 country
28
Brief Summary
To evaluate the efficacy and safety of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2024
Shorter than P25 for phase_2
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2024
CompletedFirst Posted
Study publicly available on registry
July 30, 2024
CompletedStudy Start
First participant enrolled
September 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2025
CompletedApril 11, 2025
May 1, 2024
4 months
July 24, 2024
April 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change of the maximum value of Forced Expiratory Volume in the first second (FEV1)
Change of the maximum value of FEV1 was determined from baseline to four weeks after treatment.
From baseline to four weeks after treatment
Secondary Outcomes (13)
Change of the mean value of FEV1
From baseline to four weeks after treatment
Changes in peak FEV1 values,trough FEV1 values, mean value within 3 hours after administration
From baseline to two weeks after treatment
Rescue medication
From baseline to four weeks after administration
Adverse Events (AE)
From baseline to safety visit (about 5 weeks after first dosing).
Changes in the peak value of FEV1，mean value of FEV1 within 3 hours and 12 hours after administration
From baseline to 1day after treatment
- +8 more secondary outcomes
Study Arms (3)
3mg TQC3721 Suspension for Inhalation (Twice a day)
EXPERIMENTALTwo syringes of TQC3721 suspension for inhalation (1ml:1.5mg), twice a day for 4 weeks.
6mg TQC3721 Suspension for Inhalation (Twice a day)
EXPERIMENTALone syringe of TQC3721 suspension for inhalation（1ml:6mg）and one TQC3721 suspension placebo for inhalation (1ml:0mg), twice a day for 4 weeks.
Placebo for TQC3721 Suspension for Inhalation (Twice a day)
PLACEBO COMPARATORTwo syringes of placebo for TQC3721 suspension for inhalation (1ml:0mg), twice a day for 4 weeks.
Interventions
TQC3721 suspension for inhalation is target inhibitor.
TQC3721 suspension for inhalation is target inhibitor.
Placebo without active drug substance.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Fu Yang People'S Hospital
Fuyang, Anhui, 236000, China
ChongQing University Fuling Hospital
Chongqing, Chongqing Municipality, 400000, China
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, 361021, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530016, China
Zunyi Medical University Affiliated Hospital
Zunyi, Guizhou, 563000, China
Cangzhou Hospital of Integrated Tcm-Wm·Hebei
Cangzhou, Hebei, 61012, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051, China
Puyang Oilfield General Hospital
Puyang, Henan, 457001, China
Shangqiu First People's Hospita
Shangqiu, Henan, 476000, China
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 024000, China
Wuxi Fifth People's Hospital
Wuxi, Jiangsu, 214000, China
Yixing People'S Hospital
Wuxi, Jiangsu, 214200, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225000, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130031, China
Siping Central People's Hospital
Siping, Jilin, 136099, China
Genertec Liaoyou Gem Flower Hospital
Panjin, Liaoning, 100007, China
Heze Municipal Hospital
Heze, Shandong, 274031, China
Shanghai JiaoTong University of medicine Ruijin Hospital
Shanghai, Shanghai Municipality, 20025, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044, China
Suining Central Hospital
Suining, Sichuan, 629000, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300041, China
TianJin 4th Center Hospital
Tianjin, Tianjin Municipality, 300142, China
The First Affiliated Hospital of Shihezi University
Shihezi, Xinjiang, 832000, China
Wenzhou University Affiliated Second Hospital
Wenzhou, Zhejiang, 325027, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2024
First Posted
July 30, 2024
Study Start
September 14, 2024
Primary Completion
January 16, 2025
Study Completion
March 6, 2025
Last Updated
April 11, 2025
Record last verified: 2024-05