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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Chicago
• Collaborator: Asphelia Pharmaceuticals

Criteria

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.