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

NCT06267261 | Completed

• 1 other identifier: KOL-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Asthma; Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Frequency of EAR and late asthma response (LAR)

  0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR)

• Severity of EAR and LAR

  0 to 6 hours (EAR) - 3 to 24 hours after exposure (LAR)

• Nasal Symptoms

  0 to 6 hours. (Total Nasal Symptoms Score from 0 to 12, 0 being the worse and 12 the better score)

Study Arms (2)

Patients with face mask

EXPERIMENTAL

Birch pollen allergen exposure in ALYATEC chamber with face mask

Device: KOLMI® surgical face mask (OP-Air)

Patients without face mask

NO INTERVENTION

Birch pollen allergen exposure in ALYATEC chamber without face mask

Interventions

KOLMI® surgical face mask (OP-Air) DEVICE

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

Patients with face mask

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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,

Sponsors & Collaborators

• Alyatec: lead
• Medicom: collaborator

Study Sites (1)

ALYATEC

Strasbourg, France

Location

Related Links

• Study results

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Frédéric de Blay, Pr

  Chest Diseases Department, Strasbourg University Hospital, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: June 7, 2021
• Primary Completion: August 23, 2021
• Study Completion: October 25, 2021
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)