Perennial Allergic Rhinitis Clinical Trial
Official title:
A Phase III, Comparative Study for the Efficacy and Safety of Bilastine 20 mg Versus Cetirizine 10 mg and Placebo in the Treatment of Perennial Allergic Rhinitis During 4 Weeks, Followed by a Long-term Safety Extension With Bilastine 20 mg
Double-blind phase: The objective of the study was to evaluate the efficacy and safety of
Bilastine 20 mg, compared to Cetirizine and placebo for the treatment of perennial allergic
rhinitis.
Open-label Phase: The objective of this extension was to evaluate the long-term safety of
Bilastine 20 mg during one year in the symptomatic treatment of perennial allergic rhinitis
Double-blind, randomized, placebo-controlled, parallel-group, international, multicenter
study followed by an open label extension. Duration of the double-blind period was 28 days
and the duration of the open label period was 12 additional months.
The primary efficacy variable of the double-blind period was the area under curve (AUC) of
total symptoms scale (TSS) from baseline (defined as the mean of 6 last points of the
patients' diary before randomization) to D28 visit according to the patient's assessment on
reflective symptoms. 650 patients were included in the study and 614 completed the
double-blind phase. Out of the 614 patients who completed the double blind period, a total
of 513 patients started the open label period with Bilastine 20 mg (83.6%)
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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