The purpose of this study is to evaluate the relative efficacy of four dosing regimens of bilastine tablets versus placebo in subjects with SAR exposed in controlled ragweed pollen using the EEC model based on the mean change from baseline in Total Nasal Symptom Scores (TNSS). Study includes male and female subjects, aged 18 and 65 years with clinical history of SAR with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons and a positive skin prick test to ragweed allergen within 12 months prior to randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
502
Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.
Placebo Tablets administered twice per day
Allied Research International - Cetero Research
Mississauga, Ontario, Canada
Total Nasal Symptom Scores (TNSS)
Time frame: within 10 days
Total Symptom Scores (TSS), Total Non-Nasal Symptom Scores (TNNSS), Total Ocular Symptoms Scores (TOSS), Area Under the Curve (AUC) of TNSS, TSS, TOSS, TNNSS, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ - EEC)
Time frame: witin 10 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.