NCT01255592已完成2 期
A Phase II Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28-Day Oral Administration of AZD5069 Twice Daily in Patients With Bronchiectasis
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
- 83
- 试验地点
- 1
- 主要终点
- Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline
研究概览
简要总结
The purpose of this study is to investigate the effect of AZD5069 in patients with bronchiectasis.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male, or female of non-child bearing potential; ie, women who are permanently or surgically sterilised or post-menopausal.
- •Aged 18 to 80 years inclusive at screening (Visit 1)
- •Have a clinical diagnosis of idiopathic or post infective bronchiectasis as diagnosed with a historical high resolution computerised tomography (HRCT) or bronchogram
- •Be sputum producers with a history of chronic expectoration on most days of most weeks of the year. Patients should have a history of spontaneously producing sputum on a daily basis and should be able to provide at least 2 of the 3 required baseline sputum samples with an average of 3 mL or more.
- •Be on a stable treatment regimen, as judged by the investigator.
排除标准
- •Any clinically significant disease or disorder
- •Patients with other latent or chronic infections or at risk of infection within 90 days before Visit 2
- •An acute exacerbation or acute respiratory infection (upper or lower) requiring oral steroids or antibiotics within 30 days prior to Visit 2
- •An FEV1 of <30% of predicted normal at Visit 1
- •Patients who have received live or live-attenuated vaccine in the 2 weeks prior to dosing (Visit 2)
- •Concomitant diagnosis of significant pulmonary disease other than bronchiectasis or COPD, including symptomatic asthma and allergic bronchopulmonary aspergillosis
- •Bronchiectasis associated with a generalised immunodeficiency disorder, where manifestations other than bronchiectasis predominate
研究组 & 干预措施
2
Placebo Comparator
Placebo dose.
干预措施: Placebo (Drug)
1
Experimental
Treatment arm AZD5069
干预措施: AZD5069 (Drug)
结局指标
主要结局
Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline
时间窗: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.
Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.
次要结局
- Ratio of the Percentage Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline(End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.)
- Change From Baseline in Weight of 24-hour Sputum Collection(Baseline and end of treatment (Day 28))
- Change From Baseline in Slow Vital Capacity (SVC)(Baseline to end of treatment (Day 28))
- Change From Baseline in Forced Vital Capacity (FVC)(Baseline to end of treatment (Day 28))
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)(Baseline to end of treatment (Day 28))
- Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75)(Baseline to end of treatment (Day 28))
- Transition Dyspnea Index (TDI) at End of Treatment (Day 28)(Baseline to end of treatment (Day 28))
- Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card(Baseline and Last 7 days on treatment)
- Change From Baseline for the Symptom Scores of the Bronkotest Diary Card(Baseline and Last 7 days on treatment)
- Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)(Baseline and end of treatment (Day 28))
- Ratio of Interleukin-1 Beta (IL-1β) in Sputum at End of Treatment Compared to Baseline(End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.)
- Ratio of Interleukin-6 (IL-6) in Sputum at End of Treatment Compared to Baseline(End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.)
- Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) in Sputum at End of Treatment Compared to Baseline(End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.)
- Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) in Sputum at End of Treatment Compared to Baseline(End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.)
- Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Sputum at End of Treatment Compared to Baseline(End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.)
- Ratio of Growth-related Oncogene-α (GRO-α) in Sputum at End of Treatment Compared to Baseline(End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.)
- Ratio of Interleukin-8 (IL-8) in Sputum at End of Treatment Compared to Baseline(End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.)
- Ratio of Neutrophil Elastase Activity in Sputum at End of Treatment Compared to Baseline(End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.)
- Ratio of Serum Amyloid A (SAA) in Serum at End of Treatment Compared to Baseline(End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.)
- Ratio of C-reactive Protein (CRP) in Serum at End of Treatment Compared to Baseline(End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.)
- Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Serum at End of Treatment Compared to Baseline(End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.)
- Ratio of Growth-related Oncogene-α (GRO-α) in Serum at End of Treatment Compared to Baseline(End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.)
- Ratio of Interleukin-6 (IL-6) in Serum at End of Treatment Compared to Baseline(End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.)
- Ratio of Interleukin-1 Beta (IL-1β) in Serum at End of Treatment Compared to Baseline(End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.)
- Ratio of Interleukin-8 (IL-8) in Serum at End of Treatment Compared to Baseline(End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.)
研究者
研究点 (1)
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