Titrating Inhaled Steroid Dose Against Mannitol Hyper-responsiveness or BTS Outcomes: Comparative Effects on Asthma Exacerbations Over 1 Year
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
研究概览
简要总结
The investigators hypothesise that titration of asthma medication against mannitol challenge results will reduce the number of mild asthma exacerbations, in one year, when compared with titration against BTS guidelines. To test this hypothesis the investigators propose a primary care, parallel treatment, patient blinded study in which matched groups of asthmatic patients will be treated in accordance either with BTS guidelines or with our treatment algorithm dependent on mannitol challenge result.
Purpose of the study is to evaluate the efficacy of a treatment algorithm based on the measurement of airway hyperresponsiveness to mannitol challenge, a surrogate marker of airway inflammation, in the long term treatment of asthma in comparison to BTS guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female asthmatics aged >/= 16 years
- •Females must be non pregnant and non lactating
- •FEV1 >/= 50% predicted
- •Mannitol PD10 </= 635 mg at end of step down period
- •No recent exacerbations of asthma requiring oral prednisolone in the previous 3 months
- •Able to perform all the techniques necessary to carry out the challenge testing and lung function and compliant with taking the study medication
- •Good inhaler technique which will be reinforced at each study visit
排除标准
- •Male or female patients aged 15 or below
- •FEV1 </= 50% predicted
- •Patients who are currently taking a pulse of oral corticosteroids
- •Patients with the following concomitant illnesses:bronchiectasis, allergic bronchopulmonary aspergillosis, COPD, heart failure, pulmonary fibrosis, rhino-sinusitis with polyps
- •Immunocompromised patients
- •Patients with recurrent LRTI
- •Patients with documented aspirin induced asthma on LRTAs
- •Pregnancy
- •Known or suspected hypersensitivity to ICS or other excipients of the MDIs
- •HIV/Hepatitis B or C positive