NCT00826969已完成4 期
Ciclesonide for the Treatment of Airway Hyperresponsiveness. The Mannitol-Asthma-Ciclesonide Study (MACS). A Double-blind, Randomized, Parallel Group Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo
研究概览
简要总结
The study objective is to investigate in a placebo-controlled, double-blind manner the effect of inhaled corticosteroid (ciclesonide) on airway hyperresponsiveness measured as having PD15 mannitol. Treatment medication will be administered as follows: 320 microgram ciclesonide or placebo will be inhaled once daily. The study duration consists of a treatment period of 4 weeks. The study will provide further data on safety of ciclesonide.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred to the pulmonology department of the university hospital Basel because of suspected asthma defined as respiratory symptoms like wheezing or cough or chest tightness.
- •Asthma symptoms partly controlled according to GINA (October 2006) 1 week prior to randomization
- •FEV1 ≥ 70% predicted
- •18 - 70 years old
排除标准
- •Smoker and ex-smoker with >10 pack years
- •Upper respiratory tract infection within the past 4 weeks.
- •ICS or oral steroids during the previous month before inclusion
- •b-blockers within the past 4 weeks
- •Current treatment with medication as defined in section concomitant medication (ICS other than study medication, ß-blockers)
- •Known malignancy
研究组 & 干预措施
1
Active Comparator
Ciclesonide 320µg
干预措施: Ciclesonide (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo
时间窗: 4 weeks
次要结局
- RDR mannitol (response-dose-ratio = %fall in FEV1 / provocation dose given)(4 weeks)
- Responsiveness to methacholine (PD20FEV1 ) and RDR methacholine after 4 weeks of treatment(4 weeks)
- mean improvement of FEV1 and PEF, mean change of the asthma control questionnaire ACQ (Juniper)(4 weeks)
- Mean change of ACQ after 4 weeks of treatment(4 weeks)
- Level of exhaled nitric oxide after 4 weeks of treatment(4 weeks)
- Mean change of AQLQ after 4 weeks of treatment(4 weeks)
- Mean change of symptoms, rescue medication use, nocturnal awakening according to GINA after 4 weeks of treatment(4 weeks)
- Exacerbation rates during the 4 weeks of treatment(4 weeks)
研究者
研究点 (1)
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