Evaluation of the Nasal and Conjunctival Response in Subjects Allergic to Birch Pollen in the ALYATEC Environmental Exposure Chamber

The aim of this study is to assess the nasal and conjunctival response in subjects allergic to birch pollen during controlled exposures in the ALYATEC environmental exposure chamber (EEC)

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis; Rhinoconjunctivitis; Allergy to Pollen
• Intervention / Treatment: Other: Exposure to placebo; Other: Exposure to allergen

Detailed Description

This is a single-center, single-blind, placebo-controlled study. The first part of the study consists of 6 exposure sessions in Alyatec EEC, including placebo and birch pollen allergen exposures.

The second part of the study involves in-field evaluations of rhinitis and conjunctivitis symptoms during birch pollen season.

Alyatec environmental exposure chamber, also called allergen challenge chamber, allows to evaluate allergic symptoms in standardized and reproducible conditions. All the metrological parameters (temperature, air flow, hygrometry ...) are controlled as well as the allergen concentration diffused in the room.

This enables to induce and observe rhinitis, conjunctivitis and asthma symptoms for up to 20 patients at the same time, in a reproducible way and without the potential perturbations or contaminations of the natural environment.

The current study aims to get specific information about allergic symptoms induced in the Alyatec EEC chamber in patients sensitized to birch pollen allergen.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grand Est
    • Strasbourg, Grand Est, France, 67000
      • Alyatec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A clinical history of allergic rhinitis to birch pollen for at least 2 consecutive pollen seasons requiring the taking of a symptomatic drug with or without associated asthma
• Positive skin prick tests for birch pollen (> 3 mm)
• IgE specific to birch > 0.75 kUI / L.
• Positive unit rapid nasal provocation test for birch pollen
• Subjects having signed informed consent
• Subjects affiliated to a social security scheme
• Subjects able to understand and complete the procedures related to the study
• Women of childbearing potential should have a negative pregnancy test throughout the study period with effective contraception

Exclusion Criteria:

• Specific immunotherapy (SIT) for birch allergens for more than a month in the 3 years preceding the screening
• Current use of Specific immunotherapy for another allergen
• Medical history of anaphylaxis following exposure to birch pollen
• Medical history of anaphylaxis linked to another allergen in the last 6 weeks
• Nasal polyps, nasal septum deviation or diagnosis of non-allergic rhinitis
• Subjects allergic to indoor environmental allergens (cat allergens, mold, dust mites) with - Obvious exposure to these allergens.
• Uncontrolled allergic pathology (rhinitis, conjunctivitis)
• Forced expiratory volume in 1 second (FEV1) <70% of predicted normal values
• Moderate to severe asthma (GINA 3 to 5)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo exposure; All patients undergo 2 placebo exposures	Other: Exposure to placebo; Patients are exposed to a placebo for 4h in the Alyatec EEC
Experimental: Birch Pollen Exposure; All patients undergo 4 allergen exposures	Other: Exposure to allergen; Patients are exposed to birch pollen allergens for 4h in the Alyatec EEC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Nasal Symptom Score	To assess the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.	4 hours exposure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale for rhinitis	To evaluate the intensity of the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.	4 hours exposure
Total Nasal Symptom Score	To evaluate the intensity of the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.	4 hours exposure
Visual Analogue Scale for conjunctivitis	To evaluate the intensity of the conjunctival response during exposure to birch allergens compared to placebo in the ALYATEC EEC.	4 hours exposure
Total Ocular Symptom Score	To evaluate the intensity of the conjunctival response during exposure to birch allergens compared to placebo in the ALYATEC EEC.	4 hours exposure
Peak Nasal Inspiratory Flow	To evaluate the nasal obstruction during exposure to birch allergens compared to placebo in the ALYATEC EEC.	4 hours exposure

Collaborators and Investigators

• Sponsor: Alyatec

Publications and helpful links

Helpful Links

• Alyatec website

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2020
• Primary Completion (Actual): October 19, 2020
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Environmental Exposure Chamber; Birch pollen; Allergen Exposure Chamber; Allergen provocation test
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: ALY-004

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