Ciclesonide for the Treatment of Airway Hyperresponsiveness: The Mannitol-Asthma-Ciclesonide-Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 主要终点
- Change of hyperresponsiveness to mannitol by measuring PD15 FEV1 after 4 weeks (improvement of more than at least 1.5 doubling dose)
研究概览
简要总结
Response of a 4 weeks treatment with daily once 320 µg ciclesonide on airway hyperresponsiveness assessed with mannitol.
Hypothesis: Treatment with inhaled ciclesonide reduces airway hyper-responsiveness in 80% of hyper-responsive patients compared to 20% only in the placebo group and the group without airway hyper-responsiveness.
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 (Global Initiative for Asthma, October 2006) 1 week prior to randomization
- •FEV1 ≥ 70% predicted
排除标准
- •Smoker and ex-smoker with >10 pack years
- •COPD (chronic obstructive pulmonary disease)
- •Upper respiratory tract infection within the past 4 weeks.
- •ICS or oral steroids during the previous month before inclusion
- •beta-blockers within the past 4 weeks
- •Current treatment with medication as defined in section concomitant medication (ICS other than study medication, ß-blockers)
- •Pregnancy
- •Known malignancy
研究组 & 干预措施
ciclesonide positive
Half of the Mannitol positive patients were given ciclesonide. Half of the Mannitol negative patients were given ciclesonide. All patients in the "ciclesonide positive" arm received ciclesonide.
干预措施: Ciclesonide (Drug)
Placebo
Half of the Mannitol positive patients were given a placebo. Half of the Mannitol negative patients were given a placebo. All patients in the "placebo" arm received placebo.
干预措施: Ciclesonide (Drug)
结局指标
主要结局
Change of hyperresponsiveness to mannitol by measuring PD15 FEV1 after 4 weeks (improvement of more than at least 1.5 doubling dose)
时间窗: 4 weeks
measurements of PD15 FEV1 (provocative dose to produce a 15% fall in FEV1), bronchial hyperresponsiveness. A 15 % reduction of FEV1 means a bronchial hyperresponsiveness
次要结局
- AQLQ (Asthma Quality of Life Questionnaire)(4 weeks)
- Change in PD20 FEV1 methacholine (Responsiveness to metacholine)(4 weeks)
- Change in FeNO (Nitric Oxide)(4 weeks)
- Change in ACQ (Asthma Control Questionnaire)(4 weeks)
研究者
Prof. Dr. Jörg Leuppi
Prof. Dr.
Cantonal Hosptal, Baselland