NCT01108783

A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine

Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Desloratadine 5 mg for the Treatment of Seasonal Allergic Rhinitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 720 (actual)
• Sponsor: Faes Farma, S.A. · Industry
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study was to determine the efficacy and tolerability of 20 mg of Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic Rhinitis.

Detailed description

Pivotal, double-blind, randomized, placebo-controlled, comparative with desloratadine, parallel group, international, multicenter study.The Primary endpoint was the Change in total reflective score on the scale of symptoms associated with seasonal allergic rhinitis indicated by patients at the baseline assessment and over the 2 weeks of the study. A total of 720 patients with seasonal allergic rhinitis were enrolled. Duration of treatment was 14 days, preceded by one week (7 days) of placebo.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Bilastine	20 mg (encapsulated) tablets QD/14 days
DRUG	Desloratadine	5 mg (encapsulated) tablets QD/14 days
DRUG	Placebo	(encapsulated) Tablets QD/14 days

Timeline

• Start date: 2003-04-01
• Primary completion: 2003-08-01
• Completion: 2004-02-01
• First posted: 2010-04-22
• Last updated: 2012-04-05