Status:
COMPLETED
Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Cat Allergic Subjects With Asthma
Lead Sponsor:
Alyatec
Conditions:
Allergic Asthma
Allergy
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2017
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04678063
Start Date
April 10 2017
End Date
July 11 2017
Last Update
December 21 2020
Active Locations (1)
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1
Alyatec
Strasbourg, Grand Est, France, 67000