A Phase II Clinical Trial of TQC3721 Suspension for Inhalation

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) Read More

Inclusion Criteria:

• 1 Sign the informed consent form before the trial, fully understand the content, process and possible adverse reactions of the test;
• 2 Capable of using the study nebulizer correctly and complying with all study restrictions and procedures;
• 3 Aged between 18 and 75 years old, both men and women;
• 4 Body mass index(BMI)=weight (kg)/height 2 (m2), BMI is 18-28 kg/m2 (including the critical value) and body weight is ≥45kg;
• 5 Subjects have no pregnancy plan and have voluntarily taken effective contraceptive measures for at least 1 month after being screened to the last use of the study drug;
• 6 12-lead electrocardiogram with QT interval corrected ≤450 msec (males) or ≤470 msec (females), QRS interval ≤120 msec, PR interval ≤200 msec and no morphologic and other clinical significant abnormalities that the investigator considered inappropriate for the study;
• 7 Ability to perform acceptable and reproducible spirometry;
• 8 Patients previously treated with LAMA or LABA who had evidence of stable use for at least 3 months prior to screening and agreed to continue use during the study period;
• 9 Capable of withholding LAMA or LABA（ Twice-Daily maintenance LAMA or LABA for at least 24 hours and Once-Daily maintenance LAMA or LABA for at least 48 hours) and SAMA、SABAs（at least 4 hours）prior to initiation of any spirometry;
• 10 According to the 2020 GOLD Guidelines, Post-bronchodilator spirometry at screening must demonstrate FEV1/FVC ratio of ≤0.70 and FEV1 must be ≥30 % to ≤80% of predicted normal;
• 11 Current or former cigarette smokers with a history of cigarette smoking ≥10 pack years (eg, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years, former cigarette smokers should stop smoke at least 6 months before visit 1).

Exclusion Criteria:

• 1 Intolerance to salbutamol or this product.
• 2 ≥1 hospitalization for COPD treatment within 6 months prior to screening.
• 3 Antibiotic treatment for lower respiratory tract infection within 3 months prior to screening.
• 4 Use of prohibited medications within the time intervals.
• 5 Patients who were currently diagnosed with asthma, active tuberculosis, lung cancer and other active lung diseases and were considered unsuitable for the study.
• 6 Previous lung resection or lung reduction surgery.
• 7 Pulmonary rehabilitation, unless such treatment has been stable from 4 weeks prior to Screening and remains stable during the study.
• 8 A history of drug or alcohol abuse in the past 3 years (14 units of alcohol consumed per week: 1 unit =360 ml of beer or 45 ml of 40% alcohol spirits or 150 ml of wine).
• 9 Have participated in a clinical trial within one month prior to screening or within 5 half-lives of the investigational drug, whichever is the longer.
• 10 Women who are breast-feeding.
• 11 A history of myocardial infarction, congestive heart failure, and unstable or uncontrolled hypertension (systolic blood pressure ≥160mmHg and diastolic blood pressure ≥100mmHg after drug control) within 6 months prior to screening.
• 12 History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localised basal cell carcinoma of the skin.
• 13 Alanine aminotransferase (ALT) or aspartate aminotransferase(AST)≥ 2 x upper limit of normal (ULN), or other abnormal test results were deemed unsuitable for inclusion by the investigator.
• 14 Required use of oxygen therapy, even on an occasional basis.
• 15 Other conditions that the investigator considered inappropriate for participation in the study.