NCT00420082

A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber

A Randomized, Double-Blind, 4 Way Cross-over, Placebo Controlled Trial to Evaluate the Onset of Action of Bilastine 20 mg vs. Placebo, Cetirizine 10 mg, and Fexofenadine 120 mg in the Vienna Challenge Chamber

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Faes Farma, S.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double blind, active and placebo controlled, 4 way crossover study in patients with seasonal allergic rhinitis. Patients will receive a single dose of bilastine 20 mg, Cetirizine 10 mg, Fexofenadine 120 mg, and placebo in the Vienna Challenge Chamber.

Detailed description

The objective of the study is to determine the effect of a single dose of bilastine 20 mg on nasal symptoms of allergic rhinitis provoked by spending 4 hours in the Vienna Challenge Chamber . This effect will be compared to that action of Cetirizine 10 mg, Fexofenadine 120 mg, and placebo. To explore the onset of action, patients will receive study drug two hours after the start of the provocation on Day 1.Patients will remain in theVCC for an additional four hours. On Day 2, patients will return to the VCC post-dose hours 22-26.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Bilastine	Encapsulated Bilastine 20 mg tablets Q.D.
DRUG	Fexofenadine	Encapsulated Fexofenadine 120 mg tablets Q.D.
DRUG	Cetirizine	Encapsulated Cetirizine 10 mg tablets Q.D.
DRUG	Placebo	Encapsulated Placebo tablets Q.D.

Timeline

• Start date: 2006-10-01
• Completion: 2006-12-01
• First posted: 2007-01-09
• Last updated: 2012-04-05

Locations

1 site across 1 country: Austria