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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06267261
• Other study ID #: KOL-001
• Status: Completed
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: October 25, 2021

Study information

• Verified date: February 2024
• Source: Alyatec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 25, 2021
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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,

Related Conditions & MeSH terms

• Allergic Asthma
• Allergic Rhinitis
• Asthma
• Rhinitis
• Rhinitis, Allergic

Intervention

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)

Locations

Country	Name	City	State
France	ALYATEC	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
Alyatec	Medicom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)

External Links

•   Study results