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

Primary Purpose

Allergic Conjunctivitis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Exposure to birch pollen in EEC
Sponsored by
Alyatec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Allergic Conjunctivitis focused on measuring Allergy, Conjunctivitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Alyatec

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exposure to birch pollen

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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

Full Information

First Posted
November 17, 2020
Last Updated
December 14, 2020
Sponsor
Alyatec
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1. Study Identification

Unique Protocol Identification Number
NCT04641130
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 13, 2017 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
September 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alyatec

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
Allergy, Conjunctivitis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposure to birch pollen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exposure to birch pollen in EEC
Intervention Description
Patients are exposed to airborne birch pollen allergen. The duration of each exposure is 4h maximum.
Primary Outcome Measure Information:
Title
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.
Description
A positive conjunctival response is defined by an Abelson score ≥ 5.
Time Frame
4 hours exposure in EEC
Secondary Outcome Measure Information:
Title
Evaluate the reproducibility of allergen exposure in the ALYATEC EEC
Description
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.
Time Frame
4 hours exposure in EEC
Title
Study the effect of EEC birch pollen exposure on symptoms of rhino-conjunctivitis.
Description
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.
Time Frame
4 hours exposure in EEC
Title
Study the effect of EEC birch pollen exposure on symptoms of rhinitis
Description
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.
Time Frame
4 hours exposure in EEC
Title
Study the effect of EEC birch pollen exposure on symptoms of conjunctivitis.
Description
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.
Time Frame
4 hours exposure in EEC
Title
Measure the amount of particles carrying the allergens.
Description
The amount of particles carrying the allergen will be measured with counters located in the exposure chamber.
Time Frame
4 hours exposure in EEC
Title
Measure the aerodynamic diameter of the particles carrying the allergens.
Description
The aerodynamic diameter of the particles carrying the allergen will be measured with counters located in the exposure chamber.
Time Frame
4 hours exposure in EEC
Title
Evaluate changes in mitochondrial respiration
Description
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
Time Frame
4 hours exposure in EEC

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric de Blay, Pr.
Organizational Affiliation
Alyatec
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alyatec
City
Strasbourg
State/Province
Grand Est
ZIP/Postal Code
67000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.alyatec.com/en/
Description
Alyatec website

Learn more about this trial

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

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