NCT01153321已完成2 期
A Single-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase IIa Study to Investigate the Effects of 100mg AZD2423 as an Oral Tablet in Subjects With Mild COPD Following Segmental Endobronchial LPS Instillation
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
- AstraZeneca
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Absolute Monocyte Count in BAL Post-LPS Challenge
研究概览
简要总结
The purpose of the study is to find out if AZD2423 can reduce inflammation in the lungs of patients with mild COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
- •≥ 40 years of age at Visit 1
- •Clinical diagnosis of COPD (GOLD stage 1)
- •FEV1 ≥ 80% of the predicted normal post-bronchodilator at Visit 1 (GOLD stage 1)
- •FEV1/FVC <70% post-bronchodilator at Visit 1 (GOLD stage 1)
排除标准
- •Any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
- •Any clinically relevant abnormal findings in physical examination, blood or urine test results, vital signs or ECG at Visit 1 that may put the subject at risk during the study, affect their ability or take part or influence the results of the study
- •A past history or current indication of renal (kidney) failure
- •Subjects at risk of active tuberculosis or of disease reactivation
- •Subjects who have had any clinically significant illness within 4 weeks before Visit 2 (start of treatment)
研究组 & 干预措施
1
Experimental
Oral treatment
干预措施: AZD2423 (Drug)
2
Placebo Comparator
Oral treatment
干预措施: AZD2423 Placebo (Drug)
结局指标
主要结局
Absolute Monocyte Count in BAL Post-LPS Challenge
时间窗: Day 11
Monocyte count in BAL post-LPS challenge (Day 11)
次要结局
- CCL2 Concentration in Blood (Post-LPS Challenge)(Day 11)
- Neutrophils in BAL (Post-LPS Challenge)(Day 11)
- CD45+ in Biopsy Sample (Post-LPS Challenge)(Day 11)
- CD3+ in Biopsy Sample (Post-LPS Challenge)(Day 11)
- Biopsy Epithelium Grade (Post-LPS Challenge)(Day 11)
- SAA Concentration in Blood (Post-LPS Challenge)(Day 11)
- IL-1β Concentration in Blood (Pre-LPS Challenge)(Day 10)
- CCL2 Concentration in BAL (Post-LPS Challenge)(Day 11)
- IL-1β Concentration in BAL (Post-LPS Challenge)(Day 11)
- SAA Concentration in Blood (Pre-LPS Challenge)(Day 10)
- Total Macrophages in Biopsy Sample (Post-LPS Challenge)(Day 11)
- TNF α Concentration in BAL (Post-LPS Challenge)(Day 11)
- IL-8 Concentration in Blood (Post-LPS Challenge)(day 11)
- TNF-α Concentration in Blood (Pre-LPS Challenge)(Day 10)
- Total Neutrophils in Biopsy Sample (Post-LPS Challenge)(Day 11)
- Biopsy PAS Reaction Grade (Post-LPS Challenge)(Day 11)
- Eosinophils in BAL (Post-LPS Challenge)(Day 11)
- TNF-α Concentration in Blood (Post-LPS Challenge)(Day 11)
- RANTES Concentration in BAL (Post-LPS Challenge)(Day 11)
- SP-D Concentration in BAL (Post-LPS Challenge)(Day 11)
- Lymphocytes in BAL (Post-LPS Challenge)(Day 11)
- Macrophages in BAL (Post-LPS Challenge)(Day 11)
- SP-D Concentration in Blood (Pre-LPS Challenge)(Day 10)
- Eosinophils in Blood (Post-LPS Challenge)(Day 11)
- Neutrophils in Blood (Pre-LPS Challenge)(Day 10)
- IL-6 Concentration in BAL (Post-LPS Challenge)(Day 11)
- CC16 Concentration in Blood (Post-LPS Challenge)(Day 11)
- Basophils in Blood (Pre-LPS Challenge)(day 10)
- Neutrophils in Blood (Post-LPS Challenge)(Day 11)
- Maximum Plasma Concentration (Cmax) of AZD2423 at Steady State(Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose)
- Time to Cmax (Tmax) of AZD2423 at Steady State(Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose)
- Number of Participants With Treatment-related or Clinically Relevant Changes in Spirometry (Forced Expiratory Volume in 1 Second [FEV1], Forced Vital Capacity [FVC] Pre-bronchodilator)(up to 47 days (visit 1 to visit 6))
- CC16 Concentration in BAL (Post-LPS Challenge)(Day 11)
- IL-8 Concentration in BAL (Post-LPS Challenge)(Day 11)
- CCL2 Concentration in Blood (Pre-LPS Challenge)(Day 10)
- IL-1β Concentration in Blood (Post-LPS Challenge)(Day 11)
- IL-6 Concentration in Blood (Pre-LPS Challenge)(Day 10)
- IL-6 Concentration in Blood (Post-LPS Challenge)(Day 11)
- SP-D Concentration in Blood (Post-LPS Challenge)(Day 11)
- Basophils in Blood (Post-LPS Challenge)(Day 11)
- Lymphocytes in Blood (Pre-LPS Challenge)(Day 10)
- Monocytes in Blood (Pre-LPS Challenge)(Day 10)
- Monocytes in Blood (Post-LPS Challenge)(Day 11)
- Number of Participants With Clinically Relevant Treatment-related Changes in Laboratory Variables Other Than Monocytes(up to 47 days (visit 1 to visit 6))
- Number of Participants With Clinically Relevant Changes in Vital Signs(up to 47 days (visit 1 to visit 6))
- Number of Participants With Clinically Relevant Changes in Physical Examination(up to 47 days (visit 1 to visit 6))
- IL-8 Concentration in Blood (Pre-LPS Challenge)(Day 10)
- Eosinophils in Blood (Pre-LPS Challenge)(Day 10)
- Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Variables(up to 47 days (visit 1 to visit 6))
- CC16 Concentration in Blood (Pre-LPS Challenge)(Day 10)
- Lymphocytes in Blood (Post-LPS Challenge)(Day 11)
- Area Under the Plasma Concentration-time Curve From Zero to 24 Hours (AUC(0-24)) of AZD2423 at Steady State(Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose)
- Area Under the Plasma Concentration-time Curve From Zero to 8 Hours (AUC(0-8)) of AZD2423 at Steady State(Day 10 pre-dose, 20 and 40 minutes post-dose, 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose)
研究者
研究点 (1)
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