Allergy Clinical Trial
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
NCT number | NCT04678063 |
Other study ID # | ALY-003 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 10, 2017 |
Est. completion date | July 11, 2017 |
Verified date | December 2020 |
Source | Alyatec |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | July 11, 2017 |
Est. primary completion date | June 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Alyatec | Strasbourg | Grand Est |
Lead Sponsor | Collaborator |
---|---|
Alyatec |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
10 hours: 4 hours of exposure in EEC then 6 hours post-exposure | |
Secondary | 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). |
28 hours: 4 hours of exposure in EEC then 24 hours post-exposure | |
Secondary | Evaluate the allergen concentration in the EEC | The measurement of allergen concentration is performed with several sensors positioned in the chamber. | 4 hours exposure in EEC | |
Secondary | 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. | 4 hours exposure in EEC | |
Secondary | 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). |
28 hours: 4 hours of exposure in EEC then 24 hours post-exposure | |
Secondary | 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). |
28 hours: 4 hours of exposure in EEC then 24 hours post-exposure |
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