Official Title: “Effect of Veramyst on the Nasal and Ocular Symptoms of the Early Reaction to Nasal Challenge With Allergen”

The purpose of this study is to help us to a better understanding of how nose and eye symptoms are related in patients with allergies.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: April 2009

Intervention(s) in this Clinical Trial

• Drug: fluticasone furoate
  • 2 puffs in each nostril once daily for 1 week
• Drug: fluticasone furoate placebo
  • 2 puffs in each nostril once daily for 1 week

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • fluticasone furoate nasal spray once daily for a week
• Placebo Comparator: 2

Primary Measures

• The primary endpoint will be the difference in change in the level of tryptase after antigen challenge between fluticasone furoate and placebo
  • Time Frame: following antigen challenge
    Safety Issue?: No

Secondary Measures

• The difference in change in symptom scores after antigen challenge between fluticasone furoate and placebo
  • Time Frame: following antigen challenge
    Safety Issue?: No

Inclusion Criteria:

• 1. Males and females between 18 and 45 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 within 14 days of study start.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Chicago

Overall Clinical Trial Officials and Contacts

Robert Naclerio, MD Principal Investigator University of Chicago  

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00791973

Study ID Number: 16367B (OC 3)

ClinicalTrials.gov Identifier: NCT00791973

Health Authority: United States: Food and Drug Administration