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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2006-12-31

Brief Summary

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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.

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Detailed Description

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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

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Bilastine 20 mg

Group Type EXPERIMENTAL

Bilastine

Intervention Type DRUG

Encapsulated Bilastine 20 mg tablets Q.D.

2

Fexofenadine 120 mg

Group Type ACTIVE_COMPARATOR

Fexofenadine

Intervention Type DRUG

Encapsulated Fexofenadine 120 mg tablets Q.D.

3

Cetirizine 10 mg

Group Type ACTIVE_COMPARATOR

Cetirizine

Intervention Type DRUG

Encapsulated Cetirizine 10 mg tablets Q.D.

4

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Encapsulated Placebo tablets Q.D.

Interventions

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Bilastine

Encapsulated Bilastine 20 mg tablets Q.D.

Intervention Type DRUG

Fexofenadine

Encapsulated Fexofenadine 120 mg tablets Q.D.

Intervention Type DRUG

Cetirizine

Encapsulated Cetirizine 10 mg tablets Q.D.

Intervention Type DRUG

Placebo

Encapsulated Placebo tablets Q.D.

Intervention Type DRUG

Other Intervention Names

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Allegra Zyrtec

Eligibility Criteria

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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