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

Last updated: July 8, 2013
Sponsor: University of Chicago
Overall Status: Completed

Phase

2/3

Condition

Common Cold

Acute Rhinitis

Allergy (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00791102
16504B (ASP2002-AR-01)
  • Ages < 55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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, wouldpreclude provision of informed consent, make participation in the study unsafe,complicate interpretation of study outcome data, or otherwise interfere with achievingthe study objectives.

Study Design

Total Participants: 20
Study Start date:
January 01, 2010
Estimated Completion Date:
December 31, 2010

Connect with a study center

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

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