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

NCT ID: NCT04641130

Last Updated: 2020-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-13
• Study Completion Date: 2017-09-11

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).

Conditions

Allergic Conjunctivitis

Keywords

Allergy; Conjunctivitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Exposure to birch pollen

Step 1: dose validation 16 subjects are exposed for 2 consecutive days (D1 + D2), to the same aerial concentration of Bet v1.

The main objective is achieved if the Abelson score is ≥ 5 on J1 or J2. If the main objective is achieved for the 60 ng/m3 concentration, 8 responder subjects will directly perform step 2.

If the main objective is not achieved for the 60 ng/m3 concentration, the subjects will be exposed between 7 to 10 days after exposure 1, to an allergen concentration of 120 ng/m3 (Exposure 2: D1 + D2).

Step 2: reproducibility Once the allergen concentration has been determined (step 1), 8 of the responder subjects from step 1 are exposed again to this same concentration, during 2 additional exposures (Exposure 3: D1 + D2 and Exposure 4: D1 + D2), at least 7 days apart.

A wash-out period of at least 7 days is observed between step 1 and 2. The duration of allergen exposure will be a maximum of 4 hours for all exposures.

Group Type: EXPERIMENTAL

Exposure to birch pollen in EEC

Intervention Type: OTHER

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

Interventions

Exposure to birch pollen in EEC

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alyatec

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric de Blay, Pr.

Role: PRINCIPAL_INVESTIGATOR

Alyatec

Locations

Alyatec

Strasbourg, Grand Est, France

Countries

France

Related Links

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

Alyatec website

Other Identifiers

ALY-002B

Identifier Type: -

Identifier Source: org_study_id