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

NCT04641130 | Completed

• 1 other identifier: ALY-002B
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  4 hours exposure in EEC

Secondary Outcomes (7)

• Evaluate the reproducibility of allergen exposure in the ALYATEC EEC

  4 hours exposure in EEC

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

  4 hours exposure in EEC

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

  4 hours exposure in EEC

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

  4 hours exposure in EEC

• Measure the amount of particles carrying the allergens.

  4 hours exposure in EEC

Study Arms (1)

Exposure to birch pollen

EXPERIMENTAL

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.

Other: Exposure to birch pollen in EEC

Interventions

Exposure to birch pollen in EEC OTHER

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

Exposure to birch pollen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• A positive conjunctival provocation test to birch during the screening visit at a dilution of 100IR/ml maximum

You may not qualify if:

• Known asthmatic subjects allergic to birch pollen
• Desensitization to birch pollen in the last 5 years
• Uncontrolled chronic pathologies (hypertension, cardiac, respiratory, renal pathology).
• Active autoimmune disease
• Uncontrolled systemic hypertension
• Pregnancy and breast feeding
• Inability to understand and act upon the information provided

Sponsors & Collaborators

• Alyatec: lead

Study Sites (1)

Alyatec

Strasbourg, Grand Est, 67000, France

Location

Related Links

• Alyatec website

MeSH Terms

Conditions

Conjunctivitis, Allergic; Hypersensitivity; Conjunctivitis

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Frédéric de Blay, Pr.

  Alyatec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: July 13, 2017
• Primary Completion: August 30, 2017
• Study Completion: September 11, 2017
• Last Updated: December 16, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)