Small Particle Inhaled Steroids in Refractory Steroid-responsive Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in sputum eosinophil count over the trial period
研究概览
简要总结
The purpose of this study is to determine whether an inhaled steroid with a small particle size can be an additional treatment option in patients with refractory eosinophilic asthma.
详细描述
We have identified a group of patients with refractory asthma who have ongoing eosinophilic airway inflammation despite high dose inhaled corticosteroids.
Traditional inhaled steroids have a relatively proximal airway distribution which may lead to inadequate treatment of the distal airways.
We aim to demonstrate that a steroid inhaler with a smaller particle size which targets the distal airways can be a useful additional treatment option in this group of patients.
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
- Quadruple (Participant, Care Provider, 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
- •Age 18-80
- •ACQ >1.5 or a requirement for oral steroids twice a year or more
- •High dose inhaled steroid (>1000mcg BDP or equivalent)
- •Treatment with or unsuccessful trial of:
- •long-acting beta agonist
- •leukotriene antagonist
- •Sputum eosinophil count >3% despite high dose inhaled steroid or >2% with serum eosinophils >0.4x10exp9/l
- •Clinical response to 2 weeks of oral prednisolone: (any one)
- •reduction in ACQ by 0.5 or more
- •increase in FEV1 by 200ml
- •normalisation of exhaled nitric oxide or reduction of >25ppb
排除标准
- •Current smoker, or ex-smoker for <12 months
- •Current treatment with an extrafine steroid inhaler
- •Respiratory infection within the last 4 weeks
- •Pregnancy or lactation
- •Poor compliance with usual asthma medication
- •Clinical diagnosis of significant bronchiectasis
- •Use of a medication which may interact with ciclesonide:
- •ketoconazole or itraconazole
- •ritonavir, nelfinavir
研究组 & 干预措施
Ciclesonide
Ciclesonide 320 microgrammes twice daily
干预措施: Ciclesonide (Drug)
Placebo
Placebo 2 inhalations twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change in sputum eosinophil count over the trial period
时间窗: 0 weeks (start), 8 weeks (finish)
Sputum will be processed for a differential cell count, with the primary outcome the difference in sputum eosinophil count between active and placebo groups at 8 weeks
次要结局
- Change in Juniper Asthma Control Questionnaire (ACQ) score(0 weeks (start), 4 weeks, 8 weeks (finish))
- Use of oral steroid over the trial period(0-8 weeks)
- Change in Juniper Asthma Quality of Life Questionnaire (AQLQ) score(0 weeks (start), 4 weeks, 8 weeks (finish))
- Number of patients with adverse events as a measure of safety and tolerability(0-8 weeks)
- Change in alveolar nitric oxide level over the trial period(0 weeks (start), 4 weeks, 8 weeks (finish))
- Change in bronchial nitric oxide level(0 weeks (start), 4 weeks, 8 weeks (finish))
- Change in prebronchodilator FEV1(0 weeks (start), 4 weeks, 8 weeks (finish))