NCT07147946尚未招募3 期
Evaluation of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial on 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
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 666
- 试验地点
- 76
- 主要终点
- Mean change in the area under the curve (AUC) of Forced Expiratory Volume in 1 second (FEV1)
研究概览
简要总结
To evaluate the efficacy 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 an informed consent form before screening and fully understand the trial content, process, and potential adverse reactions.
- •Comply with the experimental schedule and be able to use the nebulizer inhaler correctly.
- •The age range is 40 to 80 years old (including the threshold), and both male and female participants are eligible.
- •The subjects have no pregnancy plans and voluntarily take effective contraceptive measures for at least one month from screening to the last use of the study drug.
- •Patients with a clear clinical history and related symptoms of COPD before screening.
- •Capable of conducting acceptable and reproducible lung function tests.
- •COPD clinical stability (no moderate to severe COPD acute exacerbation) 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
- •A history of life-threatening COPD, including admission to the intensive care unit and/or the need for intubation.
- •COPD acute exacerbations requiring systemic hormone therapy within 3 months prior to screening visit (V1 visit) or prior to randomization visit (V2 visit).
- •Within the first 6 months of screening, there has been at least 1 hospitalization history due to acute exacerbation of COPD or pneumonia.
- •Treatment with antibiotics for upper and/or lower respiratory tract infections within 6 weeks prior to screening or randomization visit (V3 visit).
- •Simultaneously suffering from other respiratory diseases.
- •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.
- •11.Previously received TQC3721 treatment. 12.Patients who received immunosuppressant therapy within 4 weeks prior to the screening period 13.In the investigator's assessment, patients are unable to discontinue the prohibited drugs specified in the protocol during the screening and treatment phases of the study; 14.Patients with a history of uncontrolled current diseases that the investigator judges to be clinically significant; 15.A history or current evidence of clinically significant cardiovascular or cerebrovascular diseases; 16.A history of malignant tumors (cured or uncured) in any organ or system within the past 5 years; 17.Intolerance or allergy to salbutamol or other inhaled bronchodilator therapies for COPD; 18.Patients requiring long-term oxygen therapy; 19.Female subjects who are currently pregnant, breastfeeding, or planning to become pregnant during the study period after enrollment; 20.Having participated in any clinical trial of drugs or medical devices within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit; 21.Other conditions deemed unsuitable for participation in the study by the investigator.
研究组 & 干预措施
TQC3721 Suspension for Inhalation
Experimental
Inhalation of TQC3721 suspension (6mg/2ml), one unit dose twice daily for 24 weeks
干预措施: TQC3721 Suspension for inhalation (Drug)
Placebo of TQC3721 Suspension for Inhalation
Placebo Comparator
Inhalation of TQC3721 placebo, one unit dose twice daily for 24 weeks
干预措施: Placebo of TQC3721 Suspension for Inhalation (Drug)
结局指标
主要结局
Mean change in the area under the curve (AUC) of Forced Expiratory Volume in 1 second (FEV1)
时间窗: Baseline to 12 weeks after treatment
Change from baseline in mean FEV1 AUC over 0-12 hours after 12 weeks of treatment.
次要结局
- Transition Dyspnea Index (TDI) score(Baseline to 6 weeks, 12 weeks, 24 weeks after treatment)
- Chronic Obstructive Pulmonary Disease Assessment Test (CAT) score(Baseline to 6 weeks, 12 weeks, 24 weeks after treatment)
- Plasma drug peak concentration(Day 1: 0.5 hour after-dose, Week 6: 1 hour pre-dose, 0.5 hour after-dose; Week 12: 1 hour pre-dose, 0.5 hour after-dose)
- Changes in peak FEV1 value(Baseline to 6 weeks, 12 weeks, 24 weeks after treatment)
- Chronic Obstructive Pulmonary Disease Assessment Test(At 6 weeks, 12 weeks, and 24 weeks of treatment)
- Time of first acute exacerbation of moderate/severe COPD(Baseline to 24 weeks after treatment)
- Adverse event (AE)(D-28 to within 25 weeks of treatment)
- Change from baseline in rescue medication use(Baseline to 6 weeks, 12 weeks, 24 weeks after treatment.)
- Changes in trough FEV1 values(Baseline to 6 weeks, 12 weeks, 24 weeks after treatment)
- Annual rate of acute exacerbation of COPD(Baseline to 24 weeks after treatment)
- Average FEV1 AUC 0-4h(Baseline to 6 weeks, 12 weeks, 24 weeks after treatment)
- St. George's Respiratory Questionnaire(Baseline to 6 weeks, 12 weeks, 24 weeks after treatment)
- Average FEV1 AUC (6-12h)(Baseline to 12 weeks after treatment)
- Assessment of respiratory symptoms in COPD(Baseline to 6 weeks, 12 weeks, 24 weeks after treatment)
- Interleukin-6 (IL-6), Interleukin-8 (IL-8), and C-reactive protein (CRP) at Week 12 and Week 24(At Week 12 and Week 24)
研究者
研究点 (76)
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