NCT06267261

Efficacy of Face Mask in Reducing Respiratory Allergic Symptoms in Birch-allergic Subjects in ALYATEC Exposure Chamber

Clinical Evaluation of Surgical Face Mask Efficacy in Reducing Asthma and Rhinitis Symptoms in Birch-allergic Subjects in ALYATEC Environmental Exposure Chamber

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Alyatec · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Asthma
• Allergic Rhinitis

Interventions

Type	Name	Description
DEVICE	KOLMI® surgical face mask (OP-Air)	12 subjects are exposed to birch pollen allergen in ALYATEC EEC while wearing a KOLMI® surgical face mask (OP-Air)

Timeline

• Start date: 2021-06-07
• Primary completion: 2021-08-23
• Completion: 2021-10-25
• First posted: 2024-02-20
• Last updated: 2024-07-30

Locations

1 site across 1 country: France