Topical ASP-1001 (Contrast Media Formulation) and the Acute Response to Nasal Allergen Challenge (NAC)
- Conditions
- Allergic Rhinitis
- Interventions
- Drug: ASP-1001 nasal sprayDrug: Placebo for ASP-1001
- Registration Number
- NCT00791102
- Lead Sponsor
- University of Chicago
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 ASP-1001 nasal spray Topical ASP-1001 2 Placebo for ASP-1001 Placebo for Topical ASP-1001
- Primary Outcome Measures
Name Time Method Change in Sneezing Symptom 10 minutes after diluent challenge and 10 minutes after each antigen challenge Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge.
Change in Runny Nose Symptom 10 minutes after diluent challenge and 10 minutes after each antigen challenge The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge.
Change in Stuffy Nose Symptom 10 minutes after diluent challenge and 10 minutes after each antigen challenge The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge.
Change in Itching Symptom 10 minutes after diluent challenge and 10 minutes after each antigen challenge The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge.
- Secondary Outcome Measures
Name Time Method Nasal Peak Inspiratory Flow Measurements 15 minutes after diluent challenge and 15 minutes after each antigen challenge The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge.
Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment 15 minutes prior to treatment and 15 minutes post antigen challenges
Trial Locations
- Locations (1)
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States