Clinical trial NCT04641130: Clinical Validation Study in Allergic Conjunctivitis to Birch Pollen During Allergen Challenge in ALYATEC EEC
Official title: Validation and Reproducibility Study of the ALYATEC Allergen Exposure Chamber by Determining the Concentration of Birch Pollen Allergen Inducing Conjunctivitis in Subjects Allergic to Birch Pollen.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Conjunctivitis
Keywords: Allergy
Conjunctivitis
Lead sponsor: Alyatec
Sponsor class: INDUSTRY
First posted: 2020-11-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 4 hours exposure in EEC
Secondary outcomes:
measure: Evaluate the reproducibility of allergen exposure in the ALYATEC EEC
timeFrame: 4 hours exposure in EEC
measure: Study the effect of EEC birch pollen exposure on symptoms of rhino-conjunctivitis.
timeFrame: 4 hours exposure in EEC
measure: Study the effect of EEC birch pollen exposure on symptoms of rhinitis
timeFrame: 4 hours exposure in EEC
measure: Study the effect of EEC birch pollen exposure on symptoms of conjunctivitis.
timeFrame: 4 hours exposure in EEC
measure: Measure the amount of particles carrying the allergens.
timeFrame: 4 hours exposure in EEC
measure: Measure the aerodynamic diameter of the particles carrying the allergens.
timeFrame: 4 hours exposure in EEC
measure: Evaluate changes in mitochondrial respiration
timeFrame: 4 hours exposure in EEC
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Alyatec
state: Grand Est
Study officials:
affiliation: Alyatec
name: Frédéric de Blay, Pr.
role: PRINCIPAL_INVESTIGATOR
References: