Clinical trial NCT06267261: Efficacy of Face Mask in Reducing Respiratory Allergic Symptoms in Birch-allergic Subjects in ALYATEC Exposure Chamber
Official title: Clinical Evaluation of Surgical Face Mask Efficacy in Reducing Asthma and Rhinitis Symptoms in Birch-allergic Subjects in ALYATEC Environmental Exposure Chamber
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Asthma
Allergic Rhinitis
Lead sponsor: Alyatec
Sponsor class: INDUSTRY
Collaborators: name: Medicom
First posted: 2024-02-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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
* 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 Exclusion Criteria:

* 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,

Primary outcomes:
measure: Time to early asthma response (EAR)
timeFrame: 0 to 6 hours
Secondary outcomes:
measure: Frequency of EAR and late asthma response (LAR)
timeFrame: 0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR)
measure: Severity of EAR and LAR
timeFrame: 0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR)
measure: Nasal Symptoms
timeFrame: 0 to 6 hours. (Total Nasal Symptoms Score from 0 to 12, 0 being the worse and 12 the better score)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: ALYATEC
Study officials:
affiliation: Chest Diseases Department, Strasbourg University Hospital, France
name: Frédéric de Blay, Pr
role: PRINCIPAL_INVESTIGATOR
References: