Primary Objectives: * To demonstrate that the aggravation of seasonal allergic rhinitis symptoms in the presence of pollutants is observed using an Environmental Exposure Unit. * To evaluate the efficacy of fexofenadine hydrochloride in subjects suffering from seasonal allergic rhinitis symptoms aggravated in the presence of diesel exhaust particulates. Secondary Objective: To evaluate the safety of a single dose of fexofenadine hydrochloride 180 mg.
The total study duration per subject is expected to last up to 4.5 months, depending on the timing of the screening visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
Pharmaceutical form: tablet Route of administration: oral
Pharmaceutical form: tablet Route of administration: oral
Investigational Site Number
Canada, Canada
Total nasal symptom score (TNSS)
Assessed by measuring change in the area under the curve (AUC) of the TNSS during Period 1 and 2
Time frame: From hour 0 to hour 12 in Period 1 and Period 2
TNSS
Assessed by measuring change in the AUC of the TNSS from hour 2 (planned time of investigational medicinal product administration) to hour 12 in Period 3
Time frame: From hour 2 to hour 12 in Period 3
Total symptom score (TSS)
Assessed by measuring change in the AUC of TSS from hour 2 (planned time of investigational medicinal product administration) to hour 12
Time frame: From hour 2 to hour 12 in Period 3
Individual symptom score
Assessed by measuring the change in AUC of individual symptom score from hour 2 (planned time of investigational medicinal product administration) to hour 12
Time frame: From hour 2 to hour 12 in Period 3
TNSS
Assessed by change in TNSS by time point from hour 2 to hour 12
Time frame: From hour 2 to hour 12 in Period 3
Adverse events
Incidence of adverse events
Time frame: Up to 4.5 months
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