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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-12-31

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.

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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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1

Topical ASP-1001

Group Type ACTIVE_COMPARATOR

ASP-1001 nasal spray

Intervention Type DRUG

2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.

2

Placebo for Topical ASP-1001

Group Type PLACEBO_COMPARATOR

Placebo for ASP-1001

Intervention Type DRUG

2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.

Interventions

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ASP-1001 nasal spray

2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.

Intervention Type DRUG

Placebo for ASP-1001

2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Males and females between 18 and 55 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 or sinusitis within 14 days of study start.
4. Use of nasal steroids, antihistamines in the last 2 weeks.
5. FEV1\<80% of predicted at screening for subjects with history of mild asthma
6. current smokers or recent ex-smokers
7. 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.

Minimum Eligible Age

18 Days

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes