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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
31
Patients are exposed to placebo in the EEC
Patients are exposed to dose A and B for successive exposures in the EEC
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)
Alyatec
Strasbourg, Grand Est, France
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.
Time frame: 10 hours: 4 hours of exposure in EEC then 6 hours post-exposure
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).
Time frame: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
Evaluate the allergen concentration in the EEC
The measurement of allergen concentration is performed with several sensors positioned in the chamber.
Time frame: 4 hours exposure in EEC
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.
Time frame: 4 hours exposure in EEC
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).
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Time frame: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
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).
Time frame: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure