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PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm)

Seasonal Allergic Rhinitis Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, 5-arm Parallel Study to Evaluate the Pharmacokinetics/ Pharmacodynamics and Steady State Efficacy of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo Given Orally in the Treatment of the Symptoms of Seasonal Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Mode

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00574210
Study type Interventional
Source Faes Farma, S.A.
Contact
Status Completed
Phase Phase 2
Start date October 2007
Completion date February 2008
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