Efficacy of Face Mask in Reducing Respiratory Allergic Symptoms in Birch-allergic Subjects in ALYATEC Exposure Chamber
- Conditions
- Allergic AsthmaAllergic Rhinitis
- Registration Number
- NCT06267261
- Lead Sponsor
- Alyatec
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- ACT≥ 20,
- 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.
Main
- 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,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to early asthma response (EAR) 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
- Secondary Outcome Measures
Name Time Method Severity of EAR and LAR 0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR) The efficacy of face mask is evaluated by the maximum percentage of drop of FEV1during and after EEC exposure
Nasal Symptoms 0 to 6 hours. (Total Nasal Symptoms Score from 0 to 12, 0 being the worse and 12 the better score) The efficacy of face mask is evaluated with specific questionnaire (Total Nasal Symptoms Score - TNSS)
Frequency of EAR and late asthma response (LAR) 0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR) The efficacy of face mask is evaluaed by the frequency of EAR and LAR during and after birch pollen allergen exposure in EEC
Trial Locations
- Locations (1)
ALYATEC
🇫🇷Strasbourg, France
ALYATEC🇫🇷Strasbourg, France