NCT06527144已完成2 期
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
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 28
- 主要终点
- Change of the maximum value of Forced Expiratory Volume in the first second (FEV1)
研究概览
简要总结
To evaluate the efficacy and safety of TQC3721 Suspension for Inhalation in patients with moderate to severe Chronic obstructive pulmonary disease (COPD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
3mg TQC3721 Suspension for Inhalation (Twice a day)
Experimental
Two syringes of TQC3721 suspension for inhalation (1ml:1.5mg), twice a day for 4 weeks.
干预措施: 3mg TQC3721 Suspension for Inhalation (Drug)
6mg TQC3721 Suspension for Inhalation (Twice a day)
Experimental
one syringe of TQC3721 suspension for inhalation（1ml:6mg）and one TQC3721 suspension placebo for inhalation (1ml:0mg), twice a day for 4 weeks.
干预措施: 6mg TQC3721 Suspension for Inhalation (Drug)
Placebo for TQC3721 Suspension for Inhalation (Twice a day)
Placebo Comparator
Two syringes of placebo for TQC3721 suspension for inhalation (1ml:0mg), twice a day for 4 weeks.
干预措施: Placebo TQC3721 suspension for inhalation (Drug)
结局指标
主要结局
Change of the maximum value of Forced Expiratory Volume in the first second (FEV1)
时间窗: From baseline to four weeks after treatment
Change of the maximum value of FEV1 was determined from baseline to four weeks after treatment.
次要结局
- Changes in peak FEV1 values,trough FEV1 values, mean value within 3 hours after administration(From baseline to two weeks after treatment)
- Changes in peak value of FEV1 and the mean value of FEV1 within 3 hours and 12 hours(From 1day after treatment to 4 weeks after treatment)
- Change of the mean value of FEV1(From baseline to four weeks after treatment)
- Changes in Morning Valley FEV1(From baseline to four 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 Modified Medical Research Council (mMRC) Dyspnea Scale Score(Changes in mMRC score after 2 and 4 weeks of treatment compared with baseline)
- Basic Dyspnea Index (BDI)(Changes in BDI after 2 and 4 weeks of treatment compared with baseline.)
- 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)
- Changes of FEV1 at each time point(From baseline to 1day after treatment)
- Chronic obstructive pulmonary disease Assessment Test (CAT)(Changes in CAT assessment after 2 and 4 weeks of treatment compared with baseline)
- St. George's Respiratory Questionnaire (SGRQ)(Changes in SGRQ after 2 and 4 weeks of treatment compared with baseline)
- Transitional Dyspnea Index (TDI)(Changes in TDI after 2 and 4 weeks of treatment compared with baseline)
研究者
研究点 (28)
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