Efficacy of Air Cleaners in Asthmatics Allergic to Cat in ALYATEC Environmental Exposure Chamber
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Alyatec
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Frequency of early asthmatic response
研究概览
简要总结
The aim of this study is to determine the efficacy of Rowenta® "Intense Pure Air XL" air cleaner on the early and late bronchial response, in cat-allergic asthmatic patients during an allergen exposure in ALYATEC environmental chamber (EEC)
详细描述
A monocentric, double-blind, placebo-controlled, cross-over study conducted outside of the pollen season. The study lasts 3 months for each patient, which includes a screening period, two exposure visits in the Alyatec Environmental Exposure Chamber (EEC) with active or placebo air cleaners, and a follow-up visit.
Patients with early asthmatic reaction during baseline exposure are randomly allocated to one of two sequences: active air cleaners /placebo or placebo/active air cleaners. Randomization is balanced (1:1) between the two sequences. There is a 3-week wash-out period between the two exposures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Controlled intermittent asthma (step 1 treatment, according to GINA Guideline 2016) with or without association with cat allergy related rhino-conjunctivitis;
- •Sensitization to cat allergen extract as defined by skin prick test for cat extract with a wheal diameter of ≥3 mm greater than negative control (ALK, HØrsholm, Denmark) and specific IgE anti Fel d 1 ≥ 0.7 kU/L ( ImmunoCAP, Thermofisher, Uppsala, Sweden);
- •FEV1 ≥ 70% of the predicted value;
- •No cat exposure at home or outside of the home during the study;
- •Positive methacholine challenge test performed using an AeroDoseur DTF-Atomisor ATO-AD 12 (Saint-Etienne, France);
- •Early asthmatic response during baseline cat allergen exposure.
排除标准
- •Uncontrolled asthma, asthma control test inferior to 20 within the 4 weeks preceding the study.
- •Uncontrolled asthma 2 weeks after stopping LABA treatment.
- •LABA treatment within the 2 weeks preceding the study.
- •Severe asthma (> GINA 2)
- •Subject lives with a cat
- •Cat desensibilisation within the 6 previous months.
- •Active smoker
结局指标
主要结局
Frequency of early asthmatic response
时间窗: Week 9
In subjects exposed in the EEC to an average cat allergen concentration of 40 ng/m3 (Feld1) in presence of an active air cleaner compared to a placebo. Early asthmatic response is defined by a drop of at least 20% compared to baseline FEV1.
次要结局
- Frequency of late asthmatic response(Week 9)
- Difference of asthma symptoms during exposure to cat allergen with active air cleaners versus placebo.(Week 9)
- Severity of early and/or late asthmatic response(Week 9)
- Difference of rhinitis symptoms during exposure to cat allergen with active air cleaners versus placebo.(Week 9)
- Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.(Week 9)