Alyatec
Strasbourg, Grand Est, 67000, France
NCT Number: NCT04663880
This is a randomized, double blind, cross-over study designed to determine the concentration of airborne house dust mite allergen inducing bronchial response in asthmatic subjects allergic to mite, 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 house dust mite allergen in Alyatec EEC.
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Notify Me18 year–50 year
All sexes
Interventional
Not applicable
Strasbourg, Grand Est, 67000, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Group A:
Group B:
Exclusion criteria
Patients are exposed to placebo (saline solution) in the EEC for 4h maximum
Patients are exposed to different concentrations of airborne HDM allergen (Der p1) in the EEC for 4h maximum
Patients are exposed to a single concentration of airborne HDM allergen (Der p1) in the EEC for 4h maximum
Time frame: 10 hours: 4 hours of exposure in the EEC then 6 hours post-exposure.
The bronchial response is evaluated by measuring FEV1 value during EEC exposure.
Early asthmatic response (EAR) occurs when a 20% drop in FEV1 is detected during the exposure compared to the pre-exposure FEV1.
Late bronchial response (LAR) occurs when a 15% drop in FEV1 or 20% drop in peak flow is detected 1 to 6h after the EAR.
Time frame: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
Safety is assessed with clinical evaluations performed during the 4h of exposure in the EEC
Time frame: 4 hours of exposure in EEC
The metrology is assessed with the measure of allergen concentration and particules diameter thanks to sensors in the chamber.
Time frame: 4 hours of exposure in EEC
The specificity of the bronchial response is assessed with the HDM exposure in the EEC of asthmatic subjects non allergic to HDM.
Time frame: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
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).
Time frame: 28 hours: 4 hours of exposure in EEC then 24 hours post-exposure
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).
Alyatec
Industry
Validation Study of the ALYATEC Allergen Exposure Chamber by Determining the Concentration of House Dust Mite Allergen Inducing Early and/or Late Bronchial Response in Asthmatic Subjects Allergic to Mite
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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