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

Primary Purpose

Allergic Rhinitis, Allergy to Pollen, Rhinoconjunctivitis

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Exposure to placebo

Exposure to allergen

About this trial

This is an interventional basic science trial for Allergic Rhinitis focused on measuring Environmental Exposure Chamber, Allergen Exposure Chamber, Allergen provocation test, Birch pollen

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Alyatec

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo exposure

Birch Pollen Exposure

Arm Description

All patients undergo 2 placebo exposures

All patients undergo 4 allergen exposures

Outcomes

Primary Outcome Measures

Total Nasal Symptom Score

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

To evaluate the intensity of the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.

Total Nasal Symptom Score

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

To evaluate the intensity of the conjunctival response during exposure to birch allergens compared to placebo in the ALYATEC EEC.

Total Ocular Symptom Score

To evaluate the intensity of the conjunctival response during exposure to birch allergens compared to placebo in the ALYATEC EEC.

Peak Nasal Inspiratory Flow

To evaluate the nasal obstruction during exposure to birch allergens compared to placebo in the ALYATEC EEC.

Full Information

NCT ID

NCT04583202

First Posted

September 30, 2020

Last Updated

June 8, 2021

Sponsor

Alyatec

1. Study Identification

Unique Protocol Identification Number

NCT04583202

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

February 24, 2020 (Actual)

Primary Completion Date

October 19, 2020 (Actual)

Study Completion Date

May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alyatec

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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)

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis, Allergy to Pollen, Rhinoconjunctivitis

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo exposure

Arm Type

Placebo Comparator

Arm Description

All patients undergo 2 placebo exposures

Arm Title

Birch Pollen Exposure

Arm Type

Experimental

Arm Description

All patients undergo 4 allergen exposures

Intervention Type

Other

Intervention Name(s)

Exposure to placebo

Intervention Description

Patients are exposed to a placebo for 4h in the Alyatec EEC

Intervention Type

Other

Intervention Name(s)

Exposure to allergen

Intervention Description

Patients are exposed to birch pollen allergens for 4h in the Alyatec EEC

Primary Outcome Measure Information:

Title

Total Nasal Symptom Score

Description

To assess the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.

Time Frame

4 hours exposure

Secondary Outcome Measure Information:

Title

Visual Analogue Scale for rhinitis

Description

To evaluate the intensity of the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.

Time Frame

4 hours exposure

Title

Total Nasal Symptom Score

Description

To evaluate the intensity of the nasal response during exposure to birch allergens compared to placebo in the ALYATEC EEC.

Time Frame

4 hours exposure

Title

Visual Analogue Scale for conjunctivitis

Description

To evaluate the intensity of the conjunctival response during exposure to birch allergens compared to placebo in the ALYATEC EEC.

Time Frame

4 hours exposure

Title

Total Ocular Symptom Score

Description

To evaluate the intensity of the conjunctival response during exposure to birch allergens compared to placebo in the ALYATEC EEC.

Time Frame

4 hours exposure

Title

Peak Nasal Inspiratory Flow

Description

To evaluate the nasal obstruction during exposure to birch allergens compared to placebo in the ALYATEC EEC.

Time Frame

4 hours exposure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frédéric de Blay, Pr.

Organizational Affiliation

Alyatec

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alyatec

City

Strasbourg

State/Province

Grand Est

ZIP/Postal Code

67000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.alyatec.com/en/

Description

Alyatec website

Learn more about this trial

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

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