Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR

Study Overview
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Brief Summary
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Evaluate the relative efficacy of four dosing regimens of bilastine tablets (given either once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline in Reflective Total Nasal Symptom Scores (TNSS) assessed over 14 days of treatment.

Official Title
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A Multi-Center Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo Given Orally in The Treatment of the Symptoms of Seasonal Allergic Rhino-Conjunctivitis With Allergy to Mountain Cedar Pollen

Conditions
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Seasonal Allergic Rhinitis, Hay Fever, Allergic Conjunctivitis, Hypersensitivity

Intervention / Treatment
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* Drug: Bilastine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical history of Seasonal Allergic Rhinoconjunctivitis with seasonal onset and offset of nasal allergy symptoms documentation of a positive skin test within one year of screening to Mountain Cedar allergen Exclusion Criteria: significant medical condition significant nasal abnormality significant cardiac condition recent infection use of other allergy medication during the study

Ages Eligible for Study
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Minimum Age: 12 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Bilastine 20mg once per day | Drug: Bilastine<br>* Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets<br>|
| Experimental: 2<br>Bilastine 20mg twice per day | Drug: Bilastine<br>* Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets<br>|
| Experimental: 3<br>Bilastine 10mg once per day | Drug: Bilastine<br>* Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets<br>|
| Experimental: 4<br>Bilastine 10mg twice per day | Drug: Bilastine<br>* Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets<br>|
| Placebo Comparator: 5<br> | Drug: Placebo<br>* Placebo tablets twice daily for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nasal symptom scores |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ocular symptom scores and quality of life scores; standard safety assessments |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic Rhinitis, Mountain Cedar Pollen, Pollen Allergy, Rhinoconjunctivitis