Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Cat Allergic Subjects With Asthma
NCT ID: NCT04678063
Last Updated: 2020-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2017-04-10
2017-07-11
Brief Summary
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The study was also designed to validate the specificity of the asthmatic reaction induced by exposure to airborne cat allergen in Alyatec EEC.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
TRIPLE
Study Groups
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Asthmatic subjects allergic to cat
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.
Exposure to Placebo
Patients are exposed to placebo in the EEC
Exposure to dose A and dose B of cat allergen
Patients are exposed to dose A and B for successive exposures in the EEC
Asthmatic allergic subjects not sensitized to cat
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).
Exposure to Placebo
Patients are exposed to placebo in the EEC
Exposure to a single dose of cat allergen
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)
Interventions
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Exposure to Placebo
Patients are exposed to placebo in the EEC
Exposure to dose A and dose B of cat allergen
Patients are exposed to dose A and B for successive exposures in the EEC
Exposure to a single dose of cat allergen
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)
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Alyatec
INDUSTRY
Responsible Party
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Principal Investigators
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Frédéric de Blay, Pr.
Role: PRINCIPAL_INVESTIGATOR
Alyatec
Locations
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Alyatec
Strasbourg, Grand Est, France
Countries
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Related Links
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Alyatec website
Other Identifiers
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ALY-003
Identifier Type: -
Identifier Source: org_study_id