The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg, compared to Cetirizine and placebo for the treatment of seasonal allergic rhinitis.
In this pivotal, multicentre, international, randomized, double-blind, placebo and active-comparator controlled, parallel study, 683 patients with SAR will be enrolled. Patients will be required to be 12-70 years old, have SAR for ≥2 years, a positive skin test, total nasal and non-nasal score (TSS) ≥36 (out of 72) during run-in, and a composite instantaneous nasal symptom score ≥6 (out of 12) the morning before randomization. The primary efficacy endpoint will be the AUC of reflective TSS from baseline to Day 14.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
683
20 mg (encapsulated) tablets QD/14days
10 mg (encapsulated) tablets. QD/14 days
(encapsulated) Tablets QD/14 days
Area under curve of total symptoms score (TSS) from basal visit to D14 visit, according to the patient's assessment on reflective symptoms.
Time frame: 14 days
AUC of TSS from baseline to D14 according to the patient's assessments on instantaneous symptoms.
Time frame: 14 days
Change from baseline at day 7 and day 14 for the following: Patient-rated (reflective and instantaneous) and Investigator-rated (instantaneous; assessed during study visit) TSS, NSS, NNSS and change for each individual symptom.
Time frame: 14 days
Overall assessment of discomfort caused by SAR using a visual analogue scale (VAS) on day 7 and day 14 vs. day 0.
Investigator-rated Clinical Global Impression (CGI) - assessment of the therapeutic effect and AEs performed at day 14
Responders Rate: responders will be classified based on their TSS decrease from baseline: no responders (<25%), >25%<50%, >50%<75%, >75% and will be described by treatment group with their percentage
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