Effect of Nasaleze on Nasal Challenge With Allergen

Study Overview
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Brief Summary
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The objectives of this protocol are: to confirm the inhibitory effect of Nasaleze on the immediate response to nasal challenge with antigen, and to show that inhibition of the immediate response to nasal challenge with antigen by Nasaleze inhibits subsequent inflammatory events.

Official Title
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Effect of Nasaleze on the Early Reaction to Nasal Challenge With Allergen

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Nasaleze Spray
* Other: Placebo spray
* Biological: Allergen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Males and females between 18 and 45 years of age. History of grass and/or ragweed allergic rhinitis. Positive skin test to grass and/or ragweed antigen. Positive response to screening nasal challenge. Exclusion Criteria: Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. Pregnant or lactating women. Upper respiratory infection within 14 days of study start. FEV1<80% of predicted at screening for subjects with history of mild asthma.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: Nasaleze spray<br>Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge | Drug: Nasaleze Spray<br>* Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen<br>Biological: Allergen<br>* Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo<br>|
| Placebo Comparator: Placebo spray<br>Placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge | Other: Placebo spray<br>* Subjects are treated with placebo nasal spray then challenged with allergen<br>Biological: Allergen<br>* Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent | Change in total nasal symptom score after nasal challenges (the change is calculated as the total nasal symptom score after allergen challenge - total nasal symptom score after diluent challenge) on the second of two days of nasal challenges following one week of pretreatment with Nasaleze or placebo. The nasal symptoms included number of sneezes, symptoms of runny and stuffy nose (separately for each nostril), and itchy nose/throat symptoms. Individual symptoms were score on a scale from 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe). The maximum total nasal symptom score possible was 15 with higher scores indicating worse symptoms. | Day 2 after one week pretreatment with Nasaleze or placebo. |