NCT06434792招募中2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Dose-response Phase 2 Clinical Trial to Compare the Efficacy and Safety of Bronpass Tab. Versus Placebo in Patients With Stable COPD
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change from baseline in CAT(COPD Assessment Test) total score at Visit 5
研究概览
简要总结
This clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group dose-response phase 2 clinical trial study to evaluate the efficacy and safety of Bronpass Tab. in 96 patients with chronic obstructive pulmonary disease.
详细描述
This study is to prove that Bronpass Tab. is superior in clinical efficacy and safety in improving COPD symptoms compared to placebo for 12 weeks in patients suffering from chronic obstructive pulmonary disease.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years ≤ age
- •Patients who are diagnosed as COPD (based on the definition in the Korean Society of Tuberculosis and Respiratory Diseases COPD Guidelines)
- •Patients who meet all of the following criteria at the screening test
- •FEV1/FVC < 0.70 after bronchodilator administration
- •30% ≤ FEV1 < 80% predicted after bronchodilator administration
- •Cough or sputum-related score on the CAT ≥ 3
- •Current or former smokers with a smoking history of 10 pack-years or more at screening.
- •Patients who have listened to a detailed explanation of this clinical trial, fully understand it, and voluntarily provide written consent to participate.
排除标准
- •Patients with a current medical history of asthma (However, patients previously diagnosed as asthma who have recovered and currently have a diagnosis of COPD are eligible for participation.)
- •Patients with a medical history of respiratory diseases other than COPD
- •Patients who have undergone lung volume reduction surgery.
- •Patients with a history of lung transplantation.
- •Patients with a history of respiratory infections within 4 weeks prior to screening
- •Patients with a history of moderate or severe acute exacerbation within 4 weeks prior to screening.
- •Pregnant or lactating women.
- •Patients who are considered ineligible for this clinical trial due to other reasons as judged by the investigator.
研究组 & 干预措施
Bronpass Tab.
Experimental
Twice daily for 12 weeks
干预措施: Bronpass Tab. (Drug)
Placebo
Placebo Comparator
Twice daily for 12 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline in CAT(COPD Assessment Test) total score at Visit 5
时间窗: Time frame: 3 months(Visit 5)
次要结局
- Change from baseline in CAT cough score at Visit 3, Visit 4, and Visit 5(Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5))
- Change from baseline in CAT total score at Visit 3 and Visit 4(Time frame: 1 month(Visit 3), 2 months(Visit 4))
- Change from baseline in CAT sputum score at Visit 3, Visit 4, and Visit 5(Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5))
- Incidence of moderate and severe COPD exacerbations from baseline to Visit 5(Time frame: 3 months(Visit 5))
- Change frome baseline in PFT(Pulmonary Function Test) such as FEV1(Forced Expiratory Volume in one second), FVC(Forced Vital Capacity), FEV1/FVC at Visit 5(Time frame: 3 months(Visit 5))
- Change from baseline in SGRQ-C(St. George's Respiratory Questionnaire for COPD patients) Score at Visit 3, Visit 4, and Visit 5(Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5))
- Change from baseline in COAT(Cough Assessment Test) Score at Visit 3, Visit 4, and Visit 5(Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5))
研究者
研究点 (1)
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