ALYATEC
Strasbourg, France
NCT Number: NCT06104293
The aim of this study is to determine the optimal concentration of grass pollen allergens inducing rhinoconjunctivitis in subjects allergic to grass pollen in ALYATEC allergen exposure chamber.
Four concentrations of grass pollen allergen (Phl p 5) are tested during 3-hour exposures: 0, 30, 60 and 90 ng/m3.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Strasbourg, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Main Inclusion Criteria:
Main Exclusion Criteria:
After the screening visit, subjects are randomized into 3 groups presenting a sequence of allergen concentrations with randomly defined concentrations of Ph l p 5 (0, 30, 60 and 90 ng/m3).
Each participant undergo four different 3-hour exposure sessions to grass pollen allergen corresponding to the four different allergen concentrations.
Time frame: 0 to 3 hours
The optimal concentration of grass pollen allergens Phl p 5 in ng/m3 will be determined by evaluating the Area Under the Curve (AUC) of the rhino-conjunctivitis TSS (Total Symptoms Score).
The value of the TSS varies from 0 (no symptom) to 24 (highest symptoms)
Time frame: 0 to 3 hours
The exposure time will be determined by the time necessary to obtain the first uncorrected TSS (Total Symptoms Score) score ≥ 12 and corrected ≥ 10.
The value of the TSS varies from 0 (no symptom) to 24 (highest symptoms)
Time frame: 0 to 3 hours
The optimal concentration of grass pollen allergens Phl p 5 in ng/m3 will be determined by evaluating the Area Under the Curve (AUC) of the rhinitis-related questions of the TSS (nasal congestion, rhinorrhea, nasal itching, sneezing).
The value of the rhinitis-related questions of the TSS varies from 0 (no symptom) to 12 (highest symptoms)
Time frame: 0 to 3 hours
The frequency of bronchial response will be assessed by determining the number of subjects presenting at least one drop of FEV1 ≥ 20% during the 3 hours of exposure in ALYATEC EEC.
Time frame: 0 to 24 hours
The use of concomitant medications will be assessed by determining the number of subjects using at least one treatment during and up to 24 hours after the exposure.
Alyatec
Industry
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