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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Allergic Rhinitis

In brief

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.

Key facts

Study ID

NCT00791102

Run by

University of Chicago

People needed

20

Starts

2010-01-01

Expected to finish

2010-12-01

Last updated by the study team

2013-07-10

Who can join

Age: 0 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and females between 18 and 55 years of age.
• History of grass and/or ragweed allergic rhinitis.
• Positive skin test to grass and/or ragweed antigen.
• Positive response to screening nasal challenge.

You may not qualify if…

• Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
• Pregnant or lactating women.
• Upper respiratory infection or sinusitis within 14 days of study start.
• Use of nasal steroids, antihistamines in the last 2 weeks.
• FEV1<80% of predicted at screening for subjects with history of mild asthma
• current smokers or recent ex-smokers
• 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.

Where it is running

• University of Chicago Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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