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

The University of Chicago

Status and phase: Completed; Phase 3; Phase 2

Conditions: Allergic Rhinitis

Treatments: Drug: Placebo for ASP-1001; Drug: ASP-1001 nasal spray

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00791102

16504B (ASP2002-AR-01)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 days to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Topical ASP-1001

Treatment:

Drug: ASP-1001 nasal spray

2

Placebo Comparator group

Description:

Placebo for Topical ASP-1001

Treatment:

Drug: Placebo for ASP-1001