NCT00812045撤回2 期
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II Study to Assess the Efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients With Cystic Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- AstraZeneca
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Effect on biomarker levels in induced sputum
研究概览
简要总结
The purpose of this study is to determine the effect of AZD1236 in patients with cystic fibrosis (CF) on inflammatory biomarkers in induced sputum, after a treatment period of 4 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Have a clinical diagnosis of cystic fibrosis with an FEV1 >40% of predicted normal
- •Be able to comply with induced sputum procedure
- •post-menopausal surgically sterile female (total hysterectomy and /or bilateral total oophorectomy)
排除标准
- •Concomitant diagnosis of significant pulmonary disease other than CF-related lung disease, including symptomatic asthma and allergic bronchopulmonary aspergillosis
- •Treatment with any immunomodulatory agents within 8 weeks prior to Visit 2
- •Known to be infected with Burkholderia cepacia
研究组 & 干预措施
1
Experimental
干预措施: AZD1236 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Effect on biomarker levels in induced sputum
时间窗: 2 times at baseline and after 4 weeks treatment
Signs and symptoms (Lung function variables by spirometry, symptom scores from Diary and Health-related quality of life Questionnaire)
时间窗: At inclusion, at randomisation and after 4 weeks treatment
次要结局
- Safety and tolerability (adverse events, vital signs and laboratory safety variables)(throughout study (at inclusion, randomisation, after 4 weeks treatments and at follow-up))
- Effect on biomarkers in blood(2 times, at baseline and after 4 weeks treatment)
- Effect on biomarkers in urine(2 times, at baseline and after 4 weeks treatment)
研究者
研究点 (1)
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