Clinical Evaluation of Surgical Face Mask Efficacy in Reducing Asthma and Rhinitis Symptoms in Birch-allergic Subjects 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
- 1
- 主要终点
- Time to early asthma response (EAR)
研究概览
简要总结
There is no clinical evidence that face masks are efficient in birch pollen-induced asthma. As the use of face masks has become widespread worldwide to limit the spread of SARS-CoV-2, this study aims to demonstrate the clinical efficacy of medical masks in patients allergic to birch in the same way that clinical trial with drugs.
详细描述
All patients should have positive skin prick tests and specific IgE to birch at screening visit. 24 patients with asthma response during 1-hour baseline exposure to airborne Bet v 1 in ALYATEC environmental exposure chamber.will be randomized into 2 groups: with (n=12) and without (n=12) a KOLMI® surgical face mask (OP-Air), for a 6-hour exposure to birch allergen.
Allergic symptoms will be observed during the 6-hour exposure and compared between the 2 different groups (with and without face mask) to evaluate the efficacy of the face mask.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Subjects who signed the written informed consent,
- •Subjects covered by health social identification number,
- •Subjects able to understand and complete study-related procedures,
- •Subjects reported history of symptomatic birch pollen allergen-triggered asthma (GINA1) with associated allergic rhinitis,
- •Positive skin prick test (SPT) with cat hair extract with mean wheal diameter ≥ 5 mm compared to negative control (NaCl reaction < 2 mm),
- •Positive sIgE tests for birch tree pollen and Bet v 1 (≥0.7 kUa/L),
- •Subjects with FEV1 ≥ 70% predicted at screening and before allergen exposure,
- •Subjects with at least one drop in FEV1 ≥20% during the 1-hour baseline exposure
- •Women of childbearing potential with a negative pregnancy test throughout the study period and a highly effective contraception: oral contraceptives, condom with spermicide, intrauterine device, bilateral tubal ligation, vasectomized partner.
排除标准
- •Allergen immunotherapy to birch pollen allergen for more than 1 month in the 3 years prior to the screening visit,
- •Ongoing allergen immunotherapy to another allergen,
- •History of anaphylactic reactions to birch allergen exposure or birch allergen immunotherapy,
- •History of anaphylactic reactions to another allergen in the last 6 weeks before inclusion,
- •Nasal polyposis, deviation of nasal septum or diagnosis of uncontrolled non-allergic rhinitis,
- •Subjects allergic to indoor environmental allergens (molds, house dust mite allergens) with obvious exposure to these allergens causing allergic symptoms,
结局指标
主要结局
Time to early asthma response (EAR)
时间窗: 0 to 6 hours
The efficacy of face mask is evaluated by the time necessary to observe an EAR during birch pollen allergen exposure in EEC
次要结局
- Severity of EAR and LAR(0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR))
- Nasal Symptoms(0 to 6 hours. (Total Nasal Symptoms Score from 0 to 12, 0 being the worse and 12 the better score))
- Frequency of EAR and late asthma response (LAR)(0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR))