Effect of Nasaleze on Nasal Challenge With Allergen

University of Chicago14 enrolled

Overview

The objectives of this protocol are: 1. to confirm the inhibitory effect of Nasaleze on the immediate response to nasal challenge with antigen, and 2. to show that inhibition of the immediate response to nasal challenge with antigen by Nasaleze inhibits subsequent inflammatory events.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Allergic Rhinitis

Interventions

Nasaleze SprayDRUG

Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen

Placebo sprayOTHER

Subjects are treated with placebo nasal spray then challenged with allergen

AllergenBIOLOGICAL

Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria 1. Males and females between 18 and 45 years of age. 2. History of grass and/or ragweed allergic rhinitis. 3. Positive skin test to grass and/or ragweed antigen. 4. Positive response to screening nasal challenge. Exclusion Criteria: 1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. 2. Pregnant or lactating women. 3. Upper respiratory infection within 14 days of study start. 4. FEV1\<80% of predicted at screening for subjects with history of mild asthma.

Locations (1)

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 2 after one week pretreatment with Nasaleze or placebo.

Data from ClinicalTrials.gov

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