Effect of Nasaleze on Nasal Challenge With Allergen

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Nasaleze spray

Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge

Group Type ACTIVE_COMPARATOR

Nasaleze Spray

Intervention Type DRUG

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

Allergen

Intervention Type BIOLOGICAL

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

Placebo spray

Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge

Group Type PLACEBO_COMPARATOR

Placebo spray

Intervention Type OTHER

Subjects are treated with placebo nasal spray then challenged with allergen

Allergen

Intervention Type BIOLOGICAL

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

Interventions

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Nasaleze Spray

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

Intervention Type DRUG

Placebo spray

Subjects are treated with placebo nasal spray then challenged with allergen

Intervention Type OTHER

Allergen

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes