Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR

Faes Farma, S.A.805 enrolled

Overview

Evaluate the relative efficacy of four dosing regimens of bilastine tablets (given either once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline in Reflective Total Nasal Symptom Scores (TNSS) assessed over 14 days of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

805

Conditions

Seasonal Allergic Rhinitis Hay Fever Allergic Conjunctivitis Hypersensitivity

Interventions

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * clinical history of Seasonal Allergic Rhinoconjunctivitis with seasonal onset and offset of nasal allergy symptoms * documentation of a positive skin test within one year of screening to Mountain Cedar allergen Exclusion Criteria: * significant medical condition * significant nasal abnormality * significant cardiac condition * recent infection * use of other allergy medication during the study

Locations (13)

Oklahoma Allergy and Asthma Clinic

Oklahoma City, Oklahoma, United States

MetaClin Research Inc.

Austin, Texas, United States

Austin Clinical Research

Austin, Texas, United States

Lovelace Scientific Resources

Austin, Texas, United States

Kerrville Research Associates

Kerrville, Texas, United States

Biogenics Research Institute