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Clinical Validation Study in Allergic Conjunctivitis to Birch Pollen During Allergen Challenge in ALYATEC EEC | Clinical Trials | Clareo Health

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

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.

NCT04641130•Alyatec

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

July 13, 2017

Primary Completion Date

August 30, 2017

Completion Date

September 11, 2017

Last Updated

December 16, 2020

Enrollment

ACTUAL participants

Conditions

Allergic Conjunctivitis

Interventions

Exposure to birch pollen in EEC

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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