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

NCT ID: NCT06267261

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-07
• Study Completion Date: 2021-10-25

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.

Conditions

Allergic Asthma; Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with face mask

Birch pollen allergen exposure in ALYATEC chamber with face mask

Group Type: EXPERIMENTAL

KOLMI® surgical face mask (OP-Air)

Intervention Type: DEVICE

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

Patients without face mask

Birch pollen allergen exposure in ALYATEC chamber without face mask

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: DEVICE

Eligibility Criteria

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.

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medicom

UNKNOWN

Sponsor Role: collaborator

Alyatec

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric de Blay, Pr

Role: PRINCIPAL_INVESTIGATOR

Chest Diseases Department, Strasbourg University Hospital, France

Locations

ALYATEC

Strasbourg, , France

Countries

France

Related Links

https://www.em-consulte.com/article/1557183/evaluation-clinique-de-l-efficacite-d-un-masque-ch

Study results

Other Identifiers

KOL-001

Identifier Type: -

Identifier Source: org_study_id