Chronic obstructive pulmonary disease
Conditions
Interventions
750 µg Dosage group:750 µg TQC3721 inhalation powder,administered by inhalation,twice a day for 4 weeks
1000 µg Dosage group:1000 µg TQC3721 inhalation powder,administered by inhalation,twice a day for 4 weeks
Placebo Dosage group:Placebo for TQC3721 inhalation powder, administered by inhalation, twice a day for 4 weeks
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form before the trial and have a full understanding of the trial content, process, and potential adverse reactions. 2. Be willing and able to adhere to the trial visit schedule and procedures and use the dry powder inhaler correctly. 3. Male and female subjects aged 40 to 80 years (inclusive). 4. Body Mass Index (BMI) within the range of 18-30 kg/m² (inclusive). 5. 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. 6. 12-lead electrocardiogram (ECG) showing: heart rate of 50-100 beats per minute (bpm); corrected QT interval (QTcF) = 2 at screening. 13. Meet the concurrent medication restrictions (within the time intervals specified in the protocol) and are expected to maintain the restriction requirements during treatment. 14. 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).
Exclusion criteria
Exclusion criteria: 1. Life-threatening COPD history, including admission to the intensive care unit (ICU) and/or requirement for intubation. 2. COPD exacerbation requiring systemic corticosteroid therapy within 3 months before the screening visit (V1 visit) or before the randomization visit (V2 visit). 3. Hospitalization history due to COPD or pneumonia = 1 time within 6 months before screening. 4. 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. 5. Concurrent other respiratory diseases: a-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. 6. 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. 7. Previous pulmonary resection or lung volume reduction surgery. 8. Pulmonary rehabilitation therapy (those whose treatment has been stable for 4 weeks before screening and will remain stable during the trial may be enrolled). 9. 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). 10. Use of non-selective oral beta-blockers. 11. Previous treatment with TQC3721. 12. Patients who received immunotherapy (e.g., azathioprine, cyclophosphamide) within 4 weeks before the screening period. 13. 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. 14. 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. 15. 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: (1) Myocardial infarction, unstable angina, or stroke within the past 6 months; (2) Unstable or life-threatening arrhythmias requiring intervention within the past 3 months; (3) NYHA Class III-IV heart failure. 16. Unstable or uncontrolled hypertension (systolic blood pressure >= 160 mmHg and diastolic blood pressure >= 100 mmHg after drug control). 17. Patients with poorly controlled type 2 diabetes or fasting blood glucose > 10 mmol/L. 18. Receipt of major surgery (requiring general anesthesia) within 8 weeks before the screening visit (V1 visit), failure to fully recover from the surgery at the time of screeni
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of the maximum value of Forced Expiratory Volume in the first second (FEV1) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| changes in the peak, trough values of FEV1 and average FEV1AUC;valley concentration and Pharmacokinetics (PK) characteristics;Adverse Events(AE);Changes in Chronic obstructive pulmonary disease Assessment Test(CAT), St. George's Respiratory Questionnaire (SGRQ); | — |
Countries
China
Contacts
Public ContactFengming Luo
West China Hospital, Sichuan University
Outcome results
None listed