NCT03414541已完成2 期
A Randomised, Double-Blind, Placebo-Controlled, Exploratory Phase IIa Study To Assess The Safety And Efficacy Of Orally Administered DS102 In Chronic Obstructive Pulmonary Disease Patients
Afimmune3 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2017年9月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 3
- 主要终点
- Number of Treatment Emergent Adverse Events (TEAEs) in each treatment group leading to treatment discontinuation.
研究概览
简要总结
The purpose of this randomised, double-blind, placebo-controlled, parallel group study is to assess the safety and efficacy of orally administered DS102 capsules versus placebo in the treatment of adult patients with 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (male or female) aged 40-75 years with stable COPD at the time of screening.
- •Patients who are current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack- years are defined as 20 cigarettes a Day for 10 years, or 10 cigarettes a Day for 20 years).
- •Patients whose pre-study clinical laboratory findings do not interfere with their participation in the study, in the opinion of the Investigator.
- •Patients who are able to communicate well with the Investigator, to understand and comply with the requirements of the study, and understand and sign the written informed consent.
排除标准
- •Patients with a history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
- •Patients with significant systemic or major illness other than pulmonary disease, including coronary artery disease, liver disease, cerebrovascular disease, renal insufficiency, serious psychiatric disease, respiratory or hypertensive disease, as well as diabetes and arthritis that, in the opinion of the Investigator, would preclude the patient from participating in and completing the study.
- •Patients with known hypersensitivity to any ingredients of the study treatment.
- •Patients, in the opinion of the Investigator, not suitable to participate in the study
研究组 & 干预措施
Placebo
Placebo Comparator
Participants in this group will receive matching placebo capsules twice daily.
干预措施: Placebo (Other)
500mg DS102
Experimental
Participants in this group will receive 500 mg DS102 capsules twice daily.
干预措施: DS102 (Drug)
1000mg DS102
Experimental
Participants in this group will receive 1000 mg DS102 capsules twice daily.
干预措施: DS102 (Drug)
结局指标
主要结局
Number of Treatment Emergent Adverse Events (TEAEs) in each treatment group leading to treatment discontinuation.
时间窗: 12 Weeks
Change in induced sputum differential neutrophil count from baseline to Week 12
时间窗: 12 weeks
次要结局
- Change in induced sputum neutrophil differential count from baseline(14 weeks)
- Change in St Georges Respiratory Questionnaire (SGRQ) from baseline(14 weeks)
研究者
研究点 (3)
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