Does a Lipophilic Steroid Inhaled After an Early Allergic Reaction Affect the Late Reaction?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1.
研究概览
简要总结
The investigators propose a 3-treatment, placebo-controlled, double-dummy, double-blinded, randomized, crossover study in which single doses of placebo, will be compared to Fluticasone propionate (Flovent Diskus) 250 mcg and budesonide 400 mcg administered after allergen challenge, at cessation of the early allergic reaction (at 20% fall in FEV1 from post-allergen peak)
详细描述
The aim of this pilot study is to evaluate whether fluticasone propionate affects the late allergic reaction after a single dose post-allergen challenge administered following cessation of the early allergic reaction.
Six subjects with mild asthma will be asked to volunteer for the study.The diagnosis of asthma will be and includes the presence of variable airflow limitation and AHR (PC20 methacholine < 16 mg/mL). Subjects will be asked to participate if they demonstrate an allergen-induced early and late asthmatic response of at least 20% and 15% reduction in FEV1, respectively.
The study will consist of 4 periods, composed of a screening allergen period with 3 subsequent allergen challenge/treatment periods. Each period will be separated with a washout of at least 2 weeks. Subjects who demonstrate a dual asthmatic response in the screening period will be selected for randomization to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, 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
- •mild asthma
- •nonsmokers
- •allergen-induced early and late asthmatic response
排除标准
- •no medication other than infrequent ( < twice weekly) inhaled beta2-agonists
- •not be exposed to sensitizing allergens
- •asthma exacerbation or respiratory tract infection in the past4 weeks
研究组 & 干预措施
1
Fluticasone propionate (Flovent Diskus) 250 mcg
干预措施: Fluticasone propionate (Flovent Diskus) 250 mcg (Drug)
2
budesonide 400mcg
干预措施: budesonide 400 mcg (Drug)
3
placebo
干预措施: Placebo (Other)
结局指标
主要结局
The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1.
时间窗: Before inhalation 3 hours
The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Change in FEV1.
时间窗: 7 hours after challenge
次要结局
- The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils).(Before inhalation both evaluations (0 hours))
- The Magnitude of Allergen-induced Airway Hyperresponsiveness (Methacholine PC20) and Inflammation (Sputum Eosinophils)(24 hours methacholine and sputum)