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Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Cat Allergic Subjects With Asthma

Primary Purpose

Allergic Asthma, Allergy, Allergy to Cats

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Exposure to Placebo
Exposure to dose A and dose B of cat allergen
Exposure to a single dose of cat allergen
Sponsored by
Alyatec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Allergic Asthma focused on measuring Cat allergy, Allergic rhinitis, Allergy

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
  • Non-specific bronchial hyperreactivity (HRBNS) assessed by a positive methacholine test
  • FEV1 value > 70% of theoretical FEV1 value
  • Asthma Control Test (ACT) ≥ 20/25 in 4 weeks prior to EEC exposure
  • Women of childbearing potential should have a negative pregnancy test throughout the study period with effective contraception.

Group A:

  • Cat allergic asthma (GINA 1, 2) associated with rhinitis and / or conjunctivitis symptoms triggered during an exposure to a cat.
  • Positive skin prick-test to cat allergen extract (wheal diameter >3 mm compared to the negative control) Specific immunoglobulin E (IgE) for cat allergen > 0.7 kU/L

Group B:

  • Mild allergic asthma (GINA 1 or 2) not sensitized to cat allergen with associated rhinitis and/or conjunctivitis.
  • Negative skin prick-test and specific IgE for cat allergen
  • Positive skin prick-test and specific IgE for another allergen.

Exclusion Criteria:

  • Uncontrolled asthma, ACT asthma control questionnaire less than 20, in the last 4 weeks
  • Uncontrolled asthma 2 weeks after interruption of LABA
  • Long-term treatment by LABA, within 2 weeks prior to inclusion
  • Existence of a severe obstructive syndrome with FEV1 <70% of the theoretical value
  • Obstruction triggered by spirometric evaluations
  • Hospitalization for asthma or exacerbation in the last 4 weeks
  • Subjects treated with oral corticosteroids in the 4 weeks prior to inclusion in the study
  • History of severe acute asthma requiring hospitalization in intensive care or intubation
  • Subjects treated with biotherapy in the 4 months prior to inclusion in the study
  • Presence of a cat at home, or daily exposure to cat allergens
  • Desensitization to cat allergens in the last 6 months
  • Active tobacco: plus 10 cigarettes / day or tobacco history plus 10 PA

Sites / Locations

  • Alyatec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Asthmatic subjects allergic to cat

Asthmatic allergic subjects not sensitized to cat

Arm Description

Group A will be randomized into 2 subgroups of 10 subjects: group A1 and A2. Both subgroupes will be exposed to placebo on exposure 1 then Subgroup A1 will be exposed to dose A on exposure 2 and dose B on exposure 3. Subgroup A2 will be exposed to dose B on exposure 2 and dose A on exposure 3. Dose A and B correspond to different Allergen concentration in the EEC.

Group B will be exposed to placebo at exposure 1, and then at exposure 2, the concentration of cat allergens corresponding to the dose that achieved the main objective (Dose A or B).

Outcomes

Primary Outcome Measures

Determine the concentration of cat allergen (in ng/m3 of Der p1) necessary to induce a bronchial response in at least 60% of asthmatic subjects allergic to cat.
The bronchial response is evaluated by measuring FEV1 value. Early asthmatic response (EAR) occurs when a 20 percent drop in FEV1 is detected during the exposure compared to the pre-exposure FEV1. Late bronchial response (LAR) occurs when a 15 percent drop in FEV1 or 20 percent drop in peak flow is detected 1 to 6h after the EAR.

Secondary Outcome Measures

Evaluate the safety of allergenic exposure in EEC
Safety is assessed with an asthma symptom self-report questionnaire performed during the 4h exposure and for 24h after the end of the exposure. The score was obtained from the sum of all four individual symptom scores (chest tightness, cough, wheezing and dyspnea) with a total possible score ranging from 0 (no symptoms) to 16 (maximum symptom intensity).
Evaluate the allergen concentration in the EEC
The measurement of allergen concentration is performed with several sensors positioned in the chamber.
Evaluate the specificity of the bronchial response
The specificity of the bronchial response is assessed with the exposure to cat allergen in the EEC of asthmatic allergic subjects non sensitized to cat.
Evaluate the effect of the exposure on rhinitis symptoms
The effect of the exposure on the rhinitis response is assessed with Total Nasal Symptom Score (TNSS). The TNSS was obtained from the sum of all four individual symptom scores, with a total possible score ranging from 0 (no symptoms) to 12 (maximum symptom intensity).
Evaluate the effect of the exposure on conjunctivitis symptoms
The effect of the exposure on the conjunctivitis response is assessed with Total Ocular Symptom Score (TOSS). The TOSS was obtained from the sum of all four individual symptom scores, with a total possible score ranging from 0 (no symptoms) to 12 (maximum symptom intensity).

Full Information

First Posted
December 4, 2020
Last Updated
December 16, 2020
Sponsor
Alyatec
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1. Study Identification

Unique Protocol Identification Number
NCT04678063
Brief Title
Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Cat Allergic Subjects With Asthma
Official Title
Validation Study of the ALYATEC Allergen Exposure Chamber (EEC) by Determining the Concentration of Cat Allergen Inducing Early and/or Late Bronchial Response in Asthmatic Subjects Allergic to Cat
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
July 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, double blind, cross-over study designed to determine the concentration of airborne cat allergen inducing bronchial response in asthmatic subjects allergic to cat, during allergen exposures in the Alyatec environmental exposure chamber (EEC). The study was also designed to validate the specificity of the asthmatic reaction induced by exposure to airborne cat allergen in Alyatec EEC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Asthma, Allergy, Allergy to Cats
Keywords
Cat allergy, Allergic rhinitis, Allergy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, double blind, cross-over study including two study groups
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asthmatic subjects allergic to cat
Arm Type
Experimental
Arm Description
Group A will be randomized into 2 subgroups of 10 subjects: group A1 and A2. Both subgroupes will be exposed to placebo on exposure 1 then Subgroup A1 will be exposed to dose A on exposure 2 and dose B on exposure 3. Subgroup A2 will be exposed to dose B on exposure 2 and dose A on exposure 3. Dose A and B correspond to different Allergen concentration in the EEC.
Arm Title
Asthmatic allergic subjects not sensitized to cat
Arm Type
Active Comparator
Arm Description
Group B will be exposed to placebo at exposure 1, and then at exposure 2, the concentration of cat allergens corresponding to the dose that achieved the main objective (Dose A or B).
Intervention Type
Other
Intervention Name(s)
Exposure to Placebo
Intervention Description
Patients are exposed to placebo in the EEC
Intervention Type
Other
Intervention Name(s)
Exposure to dose A and dose B of cat allergen
Intervention Description
Patients are exposed to dose A and B for successive exposures in the EEC
Intervention Type
Other
Intervention Name(s)
Exposure to a single dose of cat allergen
Intervention Description
Patients are exposed to a single dose of cat allergen in the EEC according to the dose selected to achieve the main objective (dose A or B)
Primary Outcome Measure Information:
Title
Determine the concentration of cat allergen (in ng/m3 of Der p1) necessary to induce a bronchial response in at least 60% of asthmatic subjects allergic to cat.
Description
The bronchial response is evaluated by measuring FEV1 value. Early asthmatic response (EAR) occurs when a 20 percent drop in FEV1 is detected during the exposure compared to the pre-exposure FEV1. Late bronchial response (LAR) occurs when a 15 percent drop in FEV1 or 20 percent drop in peak flow is detected 1 to 6h after the EAR.
Time Frame
10 hours: 4 hours of exposure in EEC then 6 hours post-exposure
Secondary Outcome Measure Information:
Title
Evaluate the safety of allergenic exposure in EEC
Description
Safety is assessed with an asthma symptom self-report questionnaire performed during the 4h exposure and for 24h after the end of the exposure. The score was obtained from the sum of all four individual symptom scores (chest tightness, cough, wheezing and dyspnea) with a total possible score ranging from 0 (no symptoms) to 16 (maximum symptom intensity).
Time Frame
28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
Title
Evaluate the allergen concentration in the EEC
Description
The measurement of allergen concentration is performed with several sensors positioned in the chamber.
Time Frame
4 hours exposure in EEC
Title
Evaluate the specificity of the bronchial response
Description
The specificity of the bronchial response is assessed with the exposure to cat allergen in the EEC of asthmatic allergic subjects non sensitized to cat.
Time Frame
4 hours exposure in EEC
Title
Evaluate the effect of the exposure on rhinitis symptoms
Description
The effect of the exposure on the rhinitis response is assessed with Total Nasal Symptom Score (TNSS). The TNSS was obtained from the sum of all four individual symptom scores, with a total possible score ranging from 0 (no symptoms) to 12 (maximum symptom intensity).
Time Frame
28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
Title
Evaluate the effect of the exposure on conjunctivitis symptoms
Description
The effect of the exposure on the conjunctivitis response is assessed with Total Ocular Symptom Score (TOSS). The TOSS was obtained from the sum of all four individual symptom scores, with a total possible score ranging from 0 (no symptoms) to 12 (maximum symptom intensity).
Time Frame
28 hours: 4 hours of exposure in EEC then 24 hours post-exposure

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 Non-specific bronchial hyperreactivity (HRBNS) assessed by a positive methacholine test FEV1 value > 70% of theoretical FEV1 value Asthma Control Test (ACT) ≥ 20/25 in 4 weeks prior to EEC exposure Women of childbearing potential should have a negative pregnancy test throughout the study period with effective contraception. Group A: Cat allergic asthma (GINA 1, 2) associated with rhinitis and / or conjunctivitis symptoms triggered during an exposure to a cat. Positive skin prick-test to cat allergen extract (wheal diameter >3 mm compared to the negative control) Specific immunoglobulin E (IgE) for cat allergen > 0.7 kU/L Group B: Mild allergic asthma (GINA 1 or 2) not sensitized to cat allergen with associated rhinitis and/or conjunctivitis. Negative skin prick-test and specific IgE for cat allergen Positive skin prick-test and specific IgE for another allergen. Exclusion Criteria: Uncontrolled asthma, ACT asthma control questionnaire less than 20, in the last 4 weeks Uncontrolled asthma 2 weeks after interruption of LABA Long-term treatment by LABA, within 2 weeks prior to inclusion Existence of a severe obstructive syndrome with FEV1 <70% of the theoretical value Obstruction triggered by spirometric evaluations Hospitalization for asthma or exacerbation in the last 4 weeks Subjects treated with oral corticosteroids in the 4 weeks prior to inclusion in the study History of severe acute asthma requiring hospitalization in intensive care or intubation Subjects treated with biotherapy in the 4 months prior to inclusion in the study Presence of a cat at home, or daily exposure to cat allergens Desensitization to cat allergens in the last 6 months Active tobacco: plus 10 cigarettes / day or tobacco history plus 10 PA
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

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Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Cat Allergic Subjects With Asthma

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