A Double-blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Evaluate the Histological Changes, Cellularity, Clinical Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Aggregated Pathology Score
研究概览
简要总结
The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Men or women 40 years or above
- •FEV1 between 40 and 80% of predicted normal value post-bronchodilator
- •Clinical diagnosis of COPD
排除标准
- •Other clinically relevant disease or disorders
- •Exacerbation of COPD within 30 days
研究组 & 干预措施
AZD1981
干预措施: AZD1981 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Aggregated Pathology Score
时间窗: Before and after 1 month treatment
Composite endpoint subscores: histological grade, immunohistochemistry grade, leucocyte counts. Each subscore measured on scale 1 (normal) to 5 (worst outcome). Composite score summed across the subscores, ranging from 3 (normal) to 15 (worst outcome). Change from baseline.
Bronchoalveolar Lavage (BAL): Eosinophil Count (%)
时间窗: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Neutrophil Count (%)
时间窗: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Macrophages Count (%)
时间窗: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)
时间窗: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)
时间窗: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Total Cells Count
时间窗: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline
Induced Sputum: Eosinophil Count (%)
时间窗: Before and after 3 week treatment
Change in Induced sputum Eosinophil count (% of total) from baseline
Induced Sputum: Neutrophils Count (%)
时间窗: Before and after 3 week treatment
Change in Induced sputum Neutrophils count (% of total) from baseline
Induced Sputum: Macrophages Count (%)
时间窗: Before and after 3 week treatment
Change in Induced sputum Macrophages count (% of total) from baseline
Induced Sputum: Lymphocytes Count (%)
时间窗: Before and after 3 week treatment
Change in Induced sputum Lymphocytes count (% of total) from baseline
Induced Sputum: Epithelial Cells Count (%)
时间窗: Before and after 3 week treatment
Change in Induced sputum Epithelial cells count (% of total) from baseline
Induced Sputum: Total Cells Count
时间窗: Before and after 3 week treatment
Change in Induced sputum Total cells count from baseline
次要结局
- Forced Expiratory Volume in 1 Second (FEV1)(Before and after 1 month treatment)
- Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)(Before and after 1 month treatment)
- Peak Expiratory Flow (PEF) Morning(Before and after 1 month treatment)
- Peak Expiratory Flow (PEF) Evening(Before and after 1 month treatment)
- Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score(Before and after 1 month treatment)
- Chronic Obstructive Pulmonary Disease (COPD) Symptom Breathing Score(Before and after 1 month treatment)
- Chronic Obstructive Pulmonary Disease (COPD) Symptom Cough Score(Before and after 1 month treatment)
- Chronic Obstructive Pulmonary Disease (COPD) Symptom Sputum Score(Before and after 1 month treatment)
- Adverse Event (AE)(1 month)