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

• ClinicalTrials.gov Identifier: NCT04583202
• Recruitment Status: Completed
• First Posted: October 12, 2020
• Last Update Posted: June 9, 2021
• Sponsor: Alyatec
• Information provided by (Responsible Party): Alyatec

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	Not Applicable

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 (Clinical Trial)
• 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: February 24, 2020
• Actual Primary Completion Date: October 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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

France

Alyatec

Strasbourg, Grand Est, France, 67000

Sponsors and Collaborators

Alyatec

Investigators

• Principal Investigator: Frédéric de Blay, Pr.; Alyatec

More Information

Additional Information:

Alyatec website 

• Responsible Party: Alyatec
• ClinicalTrials.gov Identifier: NCT04583202
• Other Study ID Numbers: ALY-004
• First Posted: October 12, 2020
• Last Update Posted: June 9, 2021
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alyatec:

Environmental Exposure Chamber; Allergen Exposure Chamber; Allergen provocation test; Birch pollen

Additional relevant MeSH terms:

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