This is a randomized, double blind, active and placebo controlled, 4 way crossover study in patients with seasonal allergic rhinitis. Patients will receive a single dose of bilastine 20 mg, Cetirizine 10 mg, Fexofenadine 120 mg, and placebo in the Vienna Challenge Chamber.
The objective of the study is to determine the effect of a single dose of bilastine 20 mg on nasal symptoms of allergic rhinitis provoked by spending 4 hours in the Vienna Challenge Chamber . This effect will be compared to that action of Cetirizine 10 mg, Fexofenadine 120 mg, and placebo. To explore the onset of action, patients will receive study drug two hours after the start of the provocation on Day 1.Patients will remain in theVCC for an additional four hours. On Day 2, patients will return to the VCC post-dose hours 22-26.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
Encapsulated Bilastine 20 mg tablets Q.D.
Encapsulated Fexofenadine 120 mg tablets Q.D.
Encapsulated Cetirizine 10 mg tablets Q.D.
Allergy Center Vienna West
Vienna, Austria
Onset of action and action duration
Nasal and ocular symptom scores
Nasal airflow resistance
Nasal secretion weight
FEV1
Routine safety parameters (vital signs, ECGs, clinical laboratory tests)
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Encapsulated Placebo tablets Q.D.