Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety Extension

2014-08-27 03:13:32 | BioPortfolio


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%)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Perennial Allergic Rhinitis


Bilastine, Cetirizine, Placebo




Faes Farma, S.A.

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:13:32-0400

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Antigens from the house dust mites (DERMATOPHAGOIDES), mainly D. farinae and D. pteronyssinus. They are proteins, found in mite feces or mite extracts, that can cause ASTHMA and other allergic diseases such as perennial rhinitis (RHINITIS, ALLERGIC, PERENNIAL) and atopic dermatitis (DERMATITIS, ATOPIC). More than 11 groups of Dermatophagoides ALLERGENS have been defined. Group I allergens, such as Der f I and Der p I from the above two species, are among the strongest mite immunogens in humans.

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Inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year. The causes are usually air-borne allergens, particularly dusts, feathers, molds, animal fur, etc.

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