Phase II Study Evaluating ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis

Study Overview
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Brief Summary
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The purpose of this study is to investigate if ONO-4053 relieves symptoms of allergic rhinitis in seasonal allergic rhinitis subjects exposed to pollen under controlled conditions.

Detailed Description
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The purpose of this study is to investigate if ONO-4053 will impact allergic rhinitis symptoms in subjects with seasonal allergic rhinitis when they are exposed to pollen administered at a fixed rate in an inhalation exposure chamber compared to the standard treatment Cetirizine 10mg under the same conditions.

Official Title
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A Randomised, Placebo Controlled, Four Period Crossover Study to Evaluate the Efficacy, Safety of Oral Repeat Doses of ONO-4053 and Cetirizine in Subjects With Seasonal Allergic Rhinitis in the Vienna Challenge Chamber.

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Cetirizine
* Drug: High dose ONO-4053
* Drug: Low dose ONO-4053
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is aged between 18 and 65 years inclusive, and healthy with the exception of allergic rhinitis or mild asthma that does not require treatment and has provided written informed consent, which signifies an agreement to enter the study and comply with the restrictions and requirements listed in the informed consent form. The subject exhibits a moderate to severe response to grass pollen grains in the allergen challenge chamber at Screening. Exclusion Criteria: The subject on examination is found to have nasal structural abnormalities or nasal polyps; a history of frequent nose bleeds, nasal biopsy, nasal trauma or nasal surgery. Pregnant or breast-feeding females.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental 1<br>High dose ONO-4053 | Drug: High dose ONO-4053<br>* Experimental<br>* Other names: Experimental 1;|
| Active Comparator: Cetirizine<br>10mg Cetirizine | Drug: Cetirizine<br>* 10mg tablets<br>|
| Experimental: Experimental 2<br>Low dose ONO-4053 | Drug: Low dose ONO-4053<br>* Experimental<br>* Other names: Experimental 2;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* None active<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Nasal Symptom Score | To investigate the effect of repeat oral doses of ONO-4053 versus placebo on nasal symptoms elicited by allergen chamber challenge in subjects with seasonal allergic rhinitis. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Nasal Symptom Score | To investigate the effect of repeat oral doses of ONO-4053 versus Cetirizine on nasal symptoms (Total Nasal Symptom Score) elicited by allergen chamber challenge in subjects with allergic rhinitis. | 4 months | 
| Total Ocular Symptom Score | Itching and ocular discharge monitored daily | 4 months | 
| Pharmacokinetics | AUE (0-2h, 2-6h and 0-6h) | Days 1 and 8 |