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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis; Allergic Asthma
• Intervention / Treatment: Device: KOLMI® surgical face mask (OP-Air)

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France
    • Alyatec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with face mask; Birch pollen allergen exposure in ALYATEC chamber with face mask	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)
No Intervention: Patients without face mask; Birch pollen allergen exposure in ALYATEC chamber without face mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to early asthma response (EAR)	The efficacy of face mask is evaluated by the time necessary to observe an EAR during birch pollen allergen exposure in EEC	0 to 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of EAR and late asthma response (LAR)	The efficacy of face mask is evaluaed by the frequency of EAR and LAR during and after birch pollen allergen exposure in EEC	0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR)
Severity of EAR and LAR	The efficacy of face mask is evaluated by the maximum percentage of drop of FEV1during and after EEC exposure	0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR)
Nasal Symptoms	The efficacy of face mask is evaluated with specific questionnaire (Total Nasal Symptoms Score - TNSS)	0 to 6 hours. (Total Nasal Symptoms Score from 0 to 12, 0 being the worse and 12 the better score)

Collaborators and Investigators

• Sponsor: Alyatec
• Collaborators: Medicom
• Investigators: Principal Investigator: Frédéric de Blay, Pr, Chest Diseases Department, Strasbourg University Hospital, France

Publications and helpful links

Helpful Links

• Study results

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): August 23, 2021
• Study Completion (Actual): October 25, 2021

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Otorhinolaryngologic Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Asthma; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: KOL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No