Inhaled Allergen Challenge Methodology: Assessment of SOLO Vibrating Mesh Nebulizer for Allergen-Induced Late Asthmatic Responses
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Development of LAR after Allergen Challenge
研究概览
简要总结
This is a mechanistic study. Having established safety with the Solo® nebulizer and the ability to predict allergen PD20 using the methacholine PD20 and STE, the current study will assess the use of the Solo® vibrating mesh nebulizer on development of allergen-induced endpoints during the late phase response.
详细描述
Ten asthmatic subjects (>18 years, both sexes) who have stable asthma will be recruited to undergo inhaled allergen and diluent challenges for a randomized, 2-way crossover study. The primary objective is to compare the development of LAR between allergen (known to cause EAR and LAR) and diluent control challenges (does not cause EAR and LAR) using the Solo® vibrating mesh nebulizer using a standardized inhaled allergen challenge. Subject will undergo an allergen challenge with the Solo® compared to two different controls; diluent inhalation (a negative control with saline inhalation that does not cause LAR), and versus allergen challenge with control Wright nebulizer (positive control using a nebulizer that is known to cause LAR). Up to 2 academic centres will participate in this study. The results of this study will examine if the Solo® vibrating mesh nebulizer is an adequate substitution for the Wright nebulizer.
Screening
Skin Prick test and Skin Prick test endpoint
Randomization
The washout time after each allergen/diluent challenge triad will be 3-5 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •baseline FEV1 greater than or equal to 70%
- •positive response to inhaled methacholine (i.e. PD20 less than 400mcg)
- •evidence of atopy (i.e. positive skin prick test to an allergen that can be used for the inhalation challenge
- •absence of respiratory infection for at least 4 weeks
- •absence of allergen exposure (or other trigger of upper or lower respiratory symptoms) for at least 4 weeks
- •current nonsmoker (ex-smoker allowed; case by case basis; investigator discretion)
- •require only infrequent short-acting beta2 agonist (i.e. salbutamol or terbutaline) to treat/control asthma (i.e. no inhaled corticosteroid or combination therapies, no intranasal corticosteroid; anti-histamines etc.)
- •general good health with no other medical condition, medication use or lifestyle activities that would influence the outcome of the allergen challenge
- •development of allergen-induced early and late asthmatic responses
排除标准
- •pregnant or lactating
结局指标
主要结局
Development of LAR after Allergen Challenge
时间窗: Basline
The primary objective is to compare the development of LAR between allergen (known to cause EAR and LAR) and diluent control challenges (does not cause EAR and LAR) using the Solo® vibrating mesh nebulizer using a standardized inhaled allergen challenge.
次要结局
- Magnitude of Airway Inflammation(based on baseline methacholine challenge and skin test endpoint results)
- Development of LAR between Allergen and Diluent(based on baseline methacholine challenge and skin test endpoint results)
研究者
Gail Gauvreau
Professor
McMaster University