Efficacy of medical face masks on birch-induced asthma in ALYATEC EEC

Background: Patients with rhinitis to pollen can exhibit asthma. To control the spread of SARS-CoV-2, the use of face masks has become widespread worldwide. There is no clinical evidence that medical masks are efficient in birch pollen-induced asthma. Objective(s): To study the efficacy of medical face masks in reducing asthma in patients allergic to birch in ALYATEC Environmental Exposure Chamber (EEC). Method(s): 24 GINA 1 birch-related asthma patients, were exposed to 60 ng/m3 of airborne Bet v 1 in ALYATEC EEC. All patients had positive skin prick tests and specific IgE to birch at screening. Baseline exposures lasted 1 hour to assess asthma responses (20% drop in Forced Expiratory Volume in 1 second (FEV1). Patients with asthma were randomized into 2 groups: with and without a KOLMI face mask (OP-Air), for a 6-hour exposure to birch allergen. Result(s): At baseline, asthma occurred within 30 minutes. In group without mask, the median time for drop in FEV1 was 37 minutes, and 67 min in the group with mask (p=0.219). There was a threshold difference of time for onset of asthma between the 2 groups. At 1 hour-exposure, patients with masks still present in the EEC was twice as much as the group without masks. Asthma questionnaire was not statistically significant in both groups, but was highly correlated with the drop in FEV1 at 30 min exposure. The Kaplan Meyer graph showed that survival probability in EEC was higher for the group with masks than without masks. Borg's scale for dyspnea suggest a difference between the 2 groups starting at 2 hour-exposure. Conclusion(s): This pilot study showed a tendency of face masks to increase the time to develop asthma. Some patients reported mask effectiveness during pollen season.

Efficacy of medical face masks on birch-induced asthma in ALYATEC EEC

Rationale: To control the spread of SARS-CoV-2, the use of face masks has become widespread worldwide. There is no clinical evidence that medical masks are efficient in pollen-induced asthma. We studied the efficacy of medical face masks in reducing asthma in patients allergic to birch in ALYATEC Environmental Exposure Chamber (EEC). Methods: 24 GINA 1 birch-related asthma patients were exposed to 60 ng/m3 of airborne Bet v 1 in ALYATEC EEC. All patients had positive skin prick tests and specific IgE to birch at screening. Baseline exposures lasted 1 hour to assess asthma responses (20% drop in Forced Expiratory Volume in 1 second (FEV1), then randomized into 2 groups: with and without a KOLMI® face masks (OP-Air), for a 6-hour birch allergen exposure. Results: At baseline, asthma occurred within 30 minutes. In the group without masks, the median time for drop in FEV1 was 37 minutes, and 67 min in the group with mask (p=0.219). There was a threshold difference of time for onset of asthma between the 2 groups. At 1 hour-exposure, patients with masks still present in the EEC was twice as much as the group without masks. Asthma questionnaire score was highly correlated with the drop in FEV1 at 30 min exposure. The Kaplan Meyer graph showed that survival probability in EEC was higher for the group with masks than without masks. Conclusions: This pilot study showed a tendency of face masks to increase the time to develop asthma. Some patients reported mask effectiveness during pollen season.

Clinical evaluation of surgical face mask efficacy in reducing asthma and rhinitis symptoms in birch-allergic subjects in ALYATEC environmental exposure chamber

Aim of the study: Currently, 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, it was chosen to demonstrate the clinical efficacy of medical masks in patients allergic to birch in the same way that clinical trial with drugs. Patients and Methods: 24 birch-related asthmatic patients, were exposed to 60 ng/m3 of airborne Bet v 1 in ALYATEC environmental exposure chamber. All patients had positive skin prick tests and specific IgE to birch at screening visit. Patients with asthma response during 1-hour baseline exposure were randomized into 2 groups: with and without a KOLMI surgical face mask (OP-Air), for a 6-hour exposure to birch allergen. Result(s): The median time to obtain an early asthma response in the group without mask was 37 minutes, and 67 min in the group with mask (P = 0.219). At 1 hour-exposure, patients with masks still present in the environmental exposure chamber was twice as much as the group without masks. Conclusion(s): This pilot study showed a tendency of face masks to increase the time to develop allergic symptoms. Copyright © 2022

Évaluation clinique de l’efficacité d’un masque chirurgical dans la réduction des symptômes d’asthme et de rhinite, chez des sujets allergiques au pollen de bouleau dans la chambre d’exposition environnementale ALYATEC

Résumé But de l’étude À ce jour, aucune étude clinique n’a mis en évidence l’efficacité des masques médicaux dans l’asthme induit par le pollen de bouleau. Suite à la généralisation de l’utilisation des masques dans le monde afin de limiter la propagation du SARS-CoV-2, il a été choisi de démontrer l’efficacité des masques chirurgicaux chez des patients allergiques au pollen de bouleau, en suivant les mêmes principes que les études cliniques avec médicaments. Patients et méthodes 24 patients asthmatiques au pollen de bouleau ont été exposés à 60ng/m3 de Bet v 1 dans la chambre d’exposition environnementale ALYATEC. Tous les patients avaient des tests cutanés et des taux d’IgE spécifiques au pollen de bouleau positifs lors de la visite de sélection. Les patients présentant une réponse asthmatique pendant l’exposition baseline de 1h ont été randomisés en 2 groupes : avec et sans masque chirurgical KOLMI® (OP-Air), pour une exposition de 6h aux allergènes de pollen de bouleau. Résultats Le temps médian d’apparition d’une réponse bronchique immédiate dans le groupe sans masque était de 37minutes, et de 67min dans le groupe avec masque (p=0,219). À 1h d’exposition, le nombre de patients dans le groupe avec masque encore présents dans la chambre d’exposition environnementale était deux fois plus important que dans le groupe sans masque. Conclusion Cette étude pilote a montré une tendance des masques à retarder le temps d’apparition des symptômes allergiques. Aim of the study Currently, 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, it was chosen to demonstrate the clinical efficacy of medical masks in patients allergic to birch in the same way that clinical trial with drugs. Patients and methods 24 birch-related asthmatic patients, were exposed to 60ng/m3 of airborne Bet v 1 in ALYATEC environmental exposure chamber. All patients had positive skin prick tests and specific IgE to birch at screening visit. Patients with asthma response during 1-hour baseline exposure were randomized into 2 groups: with and without a KOLMI® surgical face mask (OP-Air), for a 6-hour exposure to birch allergen. Results The median time to obtain an early asthma response in the group without mask was 37minutes, and 67min in the group with mask (P=0.219). At 1 hour-exposure, patients with masks still present in the environmental exposure chamber was twice as much as the group without masks. Conclusion This pilot study showed a tendency of face masks to increase the time to develop allergic symptoms.