Status:
COMPLETED
Topical ASP-1001 (Contrast Media Formulation) and the Acute Response to Nasal Allergen Challenge (NAC)
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Asphelia Pharmaceuticals
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
PHASE3
Brief 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
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00791102
Start Date
January 1 2010
End Date
December 1 2010
Last Update
July 10 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Chicago Medical Center
Chicago, Illinois, United States, 60637