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

Sponsor

Alyatec (Industry)

Overall Status

Completed

CT.gov ID

NCT04583202

Collaborator

(none)

Enrollment

Location

Arms

15.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis Allergy to Pollen Rhinoconjunctivitis	Other: Exposure to placebo Other: Exposure to allergen	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Feb 24, 2020

Actual Primary Completion Date :

Oct 19, 2020

Actual Study Completion Date :

May 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Total Nasal Symptom Score [4 hours exposure]
To assess the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)