Topical ASP-1001 (Contrast Media Formulation) and the Acute Response to Nasal Allergen Challenge (NAC)

Study Overview
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Brief Summary
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The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge with antigen.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial of Topical ASP-1001 (Contrast Media Formulation) in the Prevention of the Signs and Symptoms of the Acute Response to Nasal Allergen Challenge (NAC)

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: ASP-1001 nasal spray
* Drug: Placebo for ASP-1001


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. 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 or sinusitis within 14 days of study start. Use of nasal steroids, antihistamines in the last 2 weeks. FEV1<80% of predicted at screening for subjects with history of mild asthma current smokers or recent ex-smokers 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 Days
Maximum Age: 55 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: 1<br>Topical ASP-1001 | Drug: ASP-1001 nasal spray<br>* 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.<br>|
| Placebo Comparator: 2<br>Placebo for Topical ASP-1001 | Drug: Placebo for ASP-1001<br>* 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sneezing Symptom | Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge. | 10 minutes after diluent challenge and 10 minutes after each antigen challenge | 
| Change in Runny Nose Symptom | The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge. | 10 minutes after diluent challenge and 10 minutes after each antigen challenge | 
| Change in Stuffy Nose Symptom | The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge. | 10 minutes after diluent challenge and 10 minutes after each antigen challenge | 
| Change in Itching Symptom | The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge. | 10 minutes after diluent challenge and 10 minutes after each antigen challenge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal Peak Inspiratory Flow Measurements | The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge. | 15 minutes after diluent challenge and 15 minutes after each antigen challenge | 
| Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment |  | 15 minutes prior to treatment and 15 minutes post antigen challenges |