Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Cat Allergic Subjects With Asthma (NCT04678063) | Clinical Trial Compass
CompletedNot Applicable
Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Cat Allergic Subjects With Asthma
France31 participantsStarted 2017-04-10
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
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.
Timeframe: 10 hours: 4 hours of exposure in EEC then 6 hours post-exposure