Topical Allstate and Nasal Allergen Challenge

Study Overview
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Brief Summary
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The purpose of this study is to see whether Allstate Nasal Spray when given in the nose is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever).

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial of Topical Allstate in the Prevention of the Signs and Symptoms of the Acute Response to Nasal Allergen Challenge (CETALY0001)

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Device: Allstate Nasal Spray
* Device: Placebo Nasal Spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Males and females between 18 and 55 years of age. History of grass and/or ragweed allergic rhinitis for at least 2 years. Positive skin test to grass and/or ragweed antigen within prior 12 months. Positive response to screening nasal challenge. Exclusion Criteria Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma. Use of nasal steroids, antihistamines in the last 2 weeks. Upper respiratory infection, sinusitis less than 2 weeks before screening. Structural nasal abnormalities or nasal polyps on examination, nasal ulcer, frequent nose bleeding, recent nasal surgery or nasal trauma (within 90 days). Having poorly tolerated previous administration of allergens Nasolacrimal drainage system malfunctions. Participation in other investigational therapy in the last 30 days. Any systemic disorder or medication interfering with the study. FEV1<80% of predicted at screening for subjects with mild asthma. Presence of allergic rhinitis symptoms in the screening period with TNSS >3 at baseline) Undergoing allergen desensitization therapy. Current smokers or recent ex-smokers. Not willing to give informed consent Inability to understand the nature and requirements of the study, or to comply with the study procedures. Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

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 |
| --- | --- |
| Active Comparator: Allstate Nasal Spray<br> | Device: Allstate Nasal Spray<br>* Allstate Nasal Spray, two sprays (total 100 microliters) in each nostril.<br>|
| Placebo Comparator: Placebo Nasal Spray<br> | Device: Placebo Nasal Spray<br>* 2 sprays in each nostril<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sneezes and total nasal symptom score (TNSS) (sum of nasal stuffiness, nasal discharge, and nasal itching) (scale 0-3 for each symptom; total score 0-9) are co-primary endpoints. |  | 10 minutes following each nasal challenge |