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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Bilastine
* Drug: Fexofenadine
* Drug: Cetirizine
* Drug: Placebo


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Bilastine 20 mg | Drug: Bilastine<br>* Encapsulated Bilastine 20 mg tablets Q.D.<br>|
| Active Comparator: 2<br>Fexofenadine 120 mg | Drug: Fexofenadine<br>* Encapsulated Fexofenadine 120 mg tablets Q.D.<br>* Other names: Allegra;|
| Active Comparator: 3<br>Cetirizine 10 mg | Drug: Cetirizine<br>* Encapsulated Cetirizine 10 mg tablets Q.D.<br>* Other names: Zyrtec;|
| Placebo Comparator: 4<br>Placebo | Drug: Placebo<br>* Encapsulated Placebo tablets Q.D.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of action and action duration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal and ocular symptom scores |  |  | 
| Nasal airflow resistance |  |  | 
| Nasal secretion weight |  |  | 
| FEV1 |  |  | 
| Routine safety parameters (vital signs, ECGs, clinical laboratory tests) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhinitis, Seasonal, Allergic, Pollen allergy, Environmental Exposure Chamber, Challenge Chamber