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

Allergic Conjunctivitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04641130
• Other study ID #: ALY-002B
• Status: Completed
• Phase: N/A
• Start date: July 13, 2017
• Est. completion date: September 11, 2017

Study information

• Verified date: November 2020
• Source: Alyatec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 11, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Other:
• Exposure to birch pollen in EEC
Patients are exposed to airborne birch pollen allergen. The duration of each exposure is 4h maximum.

Locations

Country	Name	City	State
France	Alyatec	Strasbourg	Grand Est

Sponsors (1)

Lead Sponsor	Collaborator
Alyatec

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	4 hours exposure in EEC
Secondary	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.	4 hours exposure in EEC
Secondary	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.	4 hours exposure in EEC
Secondary	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.	4 hours exposure in EEC
Secondary	Measure the amount of particles carrying the allergens.	The amount of particles carrying the allergen will be measured with counters located in the exposure chamber.	4 hours exposure in EEC
Secondary	Measure the aerodynamic diameter of the particles carrying the allergens.	The aerodynamic diameter of the particles carrying the allergen will be measured with counters located in the exposure chamber.	4 hours exposure in EEC
Secondary	Evaluate changes in mitochondrial respiration	The changes in mitochondrial respiration will be done by evaluating the modifications of the I to IV complex of the mitochondrial respiratory chain, before and after allergen exposure	4 hours exposure in EEC

External Links

•   Alyatec website