Nebulizer Trial: Evaluation of the Influence of Particle Size of Aerosolized AMP on Bronchial Responsiveness in Patients With Asthma and the Effects of Treatment With Ciclesonide Versus Fluticasone.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- PC20 AMP (Post-treatment Compared to Baseline)
研究概览
简要总结
The aim of this study is to compare the responsiveness of lower airways in adult patients with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily at one dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study will provide further data on safety and tolerability 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of bronchial asthma
- •FEV1 > 1.20 L
- •Positive Skin Prick Test
- •Not more than 500 mcg/day fluticasone propionate or equivalent for at least 28 days prior to baseline visit
排除标准
- •Clinically relevant abnormal laboratory values
- •Concomitant severe diseases, diseases expected to interfere with the outcome of the study and diseases which are contra-indications for the use of inhaled steroids
- •Chronic obstructive pulmonary disease (COPD) and /or other relevant lung diseases
- •One asthma exacerbation within 2 months or more than 3 exacerbations within the last year prior to baseline visit
- •Current smokers or ex-smokers with more than 10 pack years, or having smoked within 1 year prior to baseline visit
- •Positive response to saline challenge at baseline visits
- •Positive bronchial hyperresponsiveness
研究组 & 干预措施
1
Ciclesonide 160 µg
干预措施: Ciclesonide (Drug)
2
Fluticasone 100 µg
干预措施: Fluticasone (Drug)
结局指标
主要结局
PC20 AMP (Post-treatment Compared to Baseline)
时间窗: Baseline and 5 weeks
Mean change of Provocative concentration of Adenosine-5'-monophosphate (PC20 AMP) leading to a 20 percent decrease in Forced expiratory volume in one second (FEV1) between post-treatment and baseline using two different particle sizes. - Small particles = Mass mean aerodynamic diameter (MMAD) of approximately 1.04-1.08 micron - Large particles = MMAD of approximately 9.9-10.6 micron
次要结局
- Safety and Tolerability(5 weeks)
- Δ (FVC/SVC) at PC20 (AMP)(Baseline and 5 weeks)