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

Phase 2

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: Placebo; Drug: Bilastine; Drug: Fexofenadine; Drug: Cetirizine

• Registration Number: NCT00420082
• Lead Sponsor: Faes Farma, S.A.

Brief 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.

Study Timeline

• Study Start: 2006-10
• Study Completion: 2006-12
• Study First Submitted: 2007-01-08
• Study First Submitted QC: 2007-01-08
• Study First Posted: 2007-01-09
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-04
• Last Update Posted: 2012-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Have a history of seasonal allergic rhinitis
• Have a positive (as defined in the protocol) skin prick or RAST test within 12 months prior to the screening visit

Exclusion Criteria

• Have a clinically significant illness or disease
• Have unstable asthma
• Has participated in a clinical trial 30 days prior to the screening visit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4	Placebo	Placebo
1	Bilastine	Bilastine 20 mg
2	Fexofenadine	Fexofenadine 120 mg
3	Cetirizine	Cetirizine 10 mg

Primary Outcome Measures

Name	Time	Method
Onset of action and action duration

Secondary Outcome Measures

Name	Time	Method
Nasal and ocular symptom scores
Nasal airflow resistance
Nasal secretion weight
FEV1
Routine safety parameters (vital signs, ECGs, clinical laboratory tests)

Trial Locations

Locations (1)

Allergy Center Vienna West; 🇦🇹 Vienna, Austria