NCT00504933

Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis

Double-blind, Randomised, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Cetirizine 10 mg for the Treatment of Seasonal Allergic Rhinitis.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 683 (actual)
• Sponsor: Faes Farma, S.A. · Industry
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	bilastine	20 mg (encapsulated) tablets QD/14days
DRUG	Cetirizine	10 mg (encapsulated) tablets. QD/14 days
DRUG	Placebo	(encapsulated) Tablets QD/14 days

Timeline

• Start date: 2005-05-01
• Primary completion: 2005-11-01
• Completion: 2005-11-01
• First posted: 2007-07-20
• Last updated: 2012-04-05