Clinical Validation Study in Allergic Conjunctivitis to Birch Pollen During Allergen Challenge in ALYATEC EEC

Alyatec16 enrolled

Overview

This is a single center open study designed to determine the concentration of airborne birch pollen inducing an allergic conjunctivitis response in individuals allergic to birch pollen, during allergen exposures in the Alyatec environmental exposure chamber (EEC).

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Allergic Conjunctivitis

Interventions

Exposure to birch pollen in EECOTHER

Patients are exposed to airborne birch pollen allergen. The duration of each exposure is 4h maximum.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects having signed the informed consent * Subjects affiliated to a social security scheme * Subjects with birch pollen rhinitis and conjunctivitis with: * A history of rhinoconjunctivitis for at least the last 2 consecutive pollen seasons. * A positive skin prick-test to birch (wheal diameter \>6 mm compared to the negative control), * Specific immunoglobulin E (IgE) for birch\> 0.1 kIU/l * Women of childbearing potential must have a negative pregnancy test during the entire study period with an effective means of contraception: oral contraceptives, intrauterine device, condom with spermicide for at least one month before inclusion in the study and for the duration of the study. At each study visit and each exposure on D1, a urine pregnancy test will be performed. * A positive conjunctival provocation test to birch during the screening visit at a dilution of 100IR/ml maximum Exclusion Criteria: * Known asthmatic subjects allergic to birch pollen * Use of oral corticosteroids in the 4 weeks preceding inclusion in the study * Use of biotherapy in the 4 months preceding inclusion in the study * Desensitization to birch pollen in the last 5 years * Uncontrolled chronic pathologies (hypertension, cardiac, respiratory, renal pathology). * Active autoimmune disease * Uncontrolled systemic hypertension * Subjects who participated in another clinical study in the three months prior to inclusion * Pregnancy and breast feeding * Inability to understand and act upon the information provided

Locations (1)

Alyatec

Strasbourg, Grand Est, France

Outcomes

Primary Outcomes

Determine the concentration of birch pollen allergen (in ng/m3 of Bet v1) necessary to induce a conjunctival response in at least 50% of subjects allergic to birch.

A positive conjunctival response is defined by an Abelson score ≥ 5.

Time frame: 4 hours exposure in EEC

Secondary Outcomes

Evaluate the reproducibility of allergen exposure in the ALYATEC EEC

The reproducibility of the exposure will be assessed by measuring the quantity of birch pollen allergen (ng Bet v1) inducing a conjunctival response during step 2.

Time frame: 4 hours exposure in EEC

Study the effect of EEC birch pollen exposure on symptoms of rhino-conjunctivitis.

The effect of the exposure on the rhinoconjunctival response will be assessed by Rhinoconjunctivitis Total Symptom Score (RTSS). The RTSS is the sum of 6 rhinoconjunctivitis symptom scores: sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes. Each symptom is graded in a 4-point scale as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. It ranges from 0 to 18. The lower the score, the better the outcome.

Time frame: 4 hours exposure in EEC

Study the effect of EEC birch pollen exposure on symptoms of rhinitis

The effect of the exposure on the rhinitis response will be assessed by rhinitis Visual Analogue Scale (VAS). The rhinitis VAS is a measurement of patient's subjective evaluation of symptoms severity. Patients will score the severity of their nasal symptoms on a scale, with 0 meaning no symptoms and 10 meaning the worst symptoms.

Time frame: 4 hours exposure in EEC

Study the effect of EEC birch pollen exposure on symptoms of conjunctivitis.

The effect of the exposure on the conjunctival response will be assessed by Conjunctivitis Visual Analogue Scale (VAS). The conjunctivitis VAS is a measurement of patient's subjective evaluation of symptoms severity. Patients will score the severity of their ocular symptoms on a scale, with 0 meaning no symptoms and 10 meaning the worst symptoms.

Data from ClinicalTrials.gov

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