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NCT Number: NCT06267261

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

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Key information

Conditions

Allergic Asthma Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ALYATEC

Strasbourg, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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)

Primary outcomes

  1. Time to early asthma response (EAR)

    Time frame: 0 to 6 hours

    The efficacy of face mask is evaluated by the time necessary to observe an EAR during birch pollen allergen exposure in EEC

Secondary outcomes

  1. Frequency of EAR and late asthma response (LAR)

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

    The efficacy of face mask is evaluaed by the frequency of EAR and LAR during and after birch pollen allergen exposure in EEC

  2. Severity of EAR and LAR

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

    The efficacy of face mask is evaluated by the maximum percentage of drop of FEV1during and after EEC exposure

  3. Nasal Symptoms

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

    The efficacy of face mask is evaluated with specific questionnaire (Total Nasal Symptoms Score - TNSS)

Sponsors and collaborators

Lead sponsor

Alyatec

Industry

Collaborators

  • Medicom

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 20, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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