A Phase II Clinical Trial on the Efficacy and Safety of TQC3721 Inhalation Powder
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQC3721 Inhalation Powder in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
195
1 country
29
Brief Summary
To evaluate the efficacy and safety of TQC3721 inhalation powder 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 Dec 2025
Shorter than P25 for phase_2
29 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
November 19, 2025
CompletedFirst Posted
Study publicly available on registry
November 28, 2025
CompletedStudy Start
First participant enrolled
December 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
CompletedMarch 10, 2026
January 1, 2026
4 months
November 19, 2025
March 6, 2026
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 (11)
Number of subjects of changes in the peak, trough values of FEV1 and average FEV1 AUC
From baseline to four weeks after treatment
Valley concentration
From baseline to four weeks after treatment
Adverse Events (AE)
From baseline to safety visit(about 5 weeks after first dosing)
Frequency of rescue medication used during the study
From baseline to four weeks after administration
Changes in Chronic obstructive pulmonary disease Assessment Test (CAT)
From baseline to four weeks after treatment
- +6 more secondary outcomes
Study Arms (3)
750 µg Dosage group
EXPERIMENTAL750 µg TQC3721 inhalation powder，administered by inhalation，twice a day for 4 weeks.
1000 µg Dosage group
EXPERIMENTAL1000µg TQC3721 inhalation powder，administered by inhalation，twice a day for 4 weeks.
Placebo for TQC3721 inhalation powder
PLACEBO COMPARATORPlacebo for TQC3721 inhalation powder, administered by inhalation, twice a day for 4 weeks.
Interventions
TQC3721 inhalation powder is target inhibitor.
Placebo for TQC3721 inhalation powder.
Eligibility Criteria
You may qualify if:
- Sign the informed consent form before the trial and have a full understanding of the trial content, process, and potential adverse reactions.
- Be willing and able to adhere to the trial visit schedule and procedures and use the dry powder inhaler correctly.
- Male and female subjects aged 40 to 80 years (inclusive).
- Body Mass Index (BMI) within the range of 18-30 kg/m² (inclusive).
- Subjects have no plans for pregnancy and voluntarily adopt effective contraceptive measures from screening to at least 1 month after the last use of the study drug.
- lead electrocardiogram (ECG) showing: heart rate of 50-100 beats per minute (bpm); corrected QT interval (QTcF) \<= 450 msec for males or \<= 470 msec for females.
- Diagnosed with COPD according to the 2025 Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, and have had symptoms consistent with COPD for at least 1 year before screening.
- Have been on stable background inhaled therapy for COPD for at least 4 weeks before screening.
- Be able to perform acceptable and reproducible pulmonary function tests.
- At the screening visit (V1 visit), after administration of a bronchodilator (4 puffs of salbutamol), the FEV1/Forced Vital Capacity (FVC) ratio \< 0.7, and 30% predicted value \<= FEV1 \< 80% predicted value.
- Clinically stable COPD within 4 weeks before the screening visit (V1 visit) and between the V1 visit and V2 visit.
- Modified Medical Research Council (mMRC) Dyspnea Scale score \>= 2 at screening.
- Meet the concurrent medication restrictions (within the time intervals specified in the protocol) and are expected to maintain the restriction requirements during treatment.
- Smoking history \>= 10 pack-years (pack-year: number of packs per day × number of smoking years; e.g., 1 pack (20 cigarettes) per day for 10 consecutive years, or 10 cigarettes per day for 20 consecutive years).
You may not qualify if:
- Life-threatening COPD history, including admission to the intensive care unit (ICU) and/or requirement for intubation.
- COPD exacerbation requiring systemic corticosteroid therapy within 3 months before the screening visit (V1 visit) or before the randomization visit (V2 visit).
- Hospitalization history due to COPD or pneumonia ≥ 1 time within 6 months before screening.
- Antibiotic treatment for upper and/or lower respiratory tract infections within 6 weeks before screening or before the randomization visit (V3 visit). Note: Subjects with a history of lower respiratory tract infection within 6 weeks cannot be enrolled, but may be rescreened 6 weeks after recovery from the infection.
- Concurrent other respiratory diseases: α-1 antitrypsin deficiency, primary ciliary dyskinesia, lung cancer; clinically significant active pulmonary infections, pulmonary tuberculosis, bronchiectasis, pulmonary fibrosis, sarcoidosis, pulmonary hypertension, asthma, and other respiratory diseases as assessed by the investigator.
- Clinically significant abnormalities found on chest computed tomography (CT) that are not caused by COPD and judged by the investigator to have an impact on trial results or patient safety. If there is no chest CT report within 6 months before Visit 1, a chest CT examination must be performed at Visit 1.
- Previous pulmonary resection or lung volume reduction surgery.
- Pulmonary rehabilitation therapy (those whose treatment has been stable for 4 weeks before screening and will remain stable during the trial may be enrolled).
- Receipt of oral corticosteroids or roflumilast for COPD within 3 months before the screening visit (V1 visit), or receipt of oral theophylline and/or theophylline derivatives for COPD within 1 week before the screening visit (V1 visit).
- Use of non-selective oral beta-blockers.
- Previous treatment with TQC3721.
- Patients who received immunotherapy (e.g., azathioprine, cyclophosphamide) within 4 weeks before the screening period.
- As assessed by the investigator, the patient cannot discontinue the prohibited drugs specified in the protocol during the screening and treatment phases of this study.
- The patient has a history of currently uncontrolled diseases, including but not limited to endocrine, thyroid, neuropsychiatric, hepatic, gastrointestinal, renal, hematologic, urinary, immunologic, or ophthalmic diseases, which are judged to be clinically significant by the investigator.
- History or current evidence of clinically significant cardiovascular diseases, defined as any disease that the investigator believes would endanger the patient's safety if participating in the study, or any disease that may affect the efficacy or safety analysis if the disease/condition deteriorates during the study; subjects with any of the following conditions at Visit 1 will be excluded:
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chognqing, 400010, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000, China
Guigang People's Hospital
Guigang, Guangxi, 537100, China
Zunyi Medical University Affiliated Hospital
Zunyi, Guizhou, 563000, China
Puyang Oilfield General Hospital
Puyang, Henan, 457001, China
Yichang Central People's Hospital
Yichang, Hubei, 443003, China
The People's Hospital of Liuyang
Changsha, Hunan, 410000, China
Xiangtan County People's Hospital
Xiangtan, Hunan, 411200, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010000, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000, China
Yixing People'S Hospital
Wuxi, Jiangsu, 214000, China
Jiujiang First People's Hospital
Jiujiang, Jiangxi, 332000, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006, China
Siping Central People's Hospital
Siping, Jilin, 136099, China
Heze Municipal Hospital
Heze, Shandong, 274000, China
Shanghai JiaoTong University of medicine Ruijin Hospital
Shanghai, Shanghai Municipality, 20025, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
Linfen People's Hospital
Linfen, Shanxi, 41000, China
Nuclear Industry 416 Hospital
Chengdou, Sichuan, 610051, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 610044, China
Affiliated Hospital Of ChengDu University
Chengdu, Sichuan, 610081, China
West China Hospital of Sichuan University
Chengdu, Sichuan, Sichuan 610044, China
Suining Central Hospital
Suining, Sichuan, 629000, China
Yibin Second People's Hospital
Yibin, Sichuan, 644000, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
The Fourth Central Hospital of Tianjin
Tianjin, Tianjin Municipality, 300140, China
Taizhou central hospital (Taizhou university hospital）
Taizhou, Zhejiang, 31800, China
The 2th School of Medicine ,WMU/The 2th affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhu, Zhejiang, 325027, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
November 19, 2025
First Posted
November 28, 2025
Study Start
December 22, 2025
Primary Completion
May 1, 2026
Study Completion
June 1, 2026
Last Updated
March 10, 2026
Record last verified: 2026-01