Official Title: “Does the Response to a Nasal Decongestant Test Predict the Outcome to Treatment of Seasonal Allergic Rhinitis With Nasonex?”

We hypothesize that those patients with purely seasonal allergic rhinitis will decongest better than those subjects with another cause contributing to their symptoms. These latter patients will not improve as well on an intranasal steroid as those who decongest well, potentially explaining the 60% response rate in prior studies.

Study Type: Interventional

Study Design: Other, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: mometasone furoate nasal spray
  • 2 puffs in each nostril once a day for 2 weeks
• Drug: placebo
  • 2 puffs in each nostril once a day for 2 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 2 weeks of treatment
• Placebo Comparator: 2
  • 2 weeks of treatment

Primary Measures

• correlation in Nasonex group of change in airflow (nasal peak inspiratory flow)on decongestant test and global assessment
  • Time Frame: prior to and after 2 weeks of treatment
    Safety Issue?: No

Secondary Measures

• symptom diaries
  • Time Frame: over 2 weeks of treatment
    Safety Issue?: No
• changes in RQLQ
  • Time Frame: over 2 weeks of treatment
    Safety Issue?: No

Inclusion Criteria

• 1. Males and females between 18 and 60 years of age.
• 2. History of grass and/or ragweed allergic rhinitis.
• 3. Positive skin or RAST test to grass, trees and/or ragweed antigen.
• 4. Symptomatic at time of entry into study.

Exclusion Criteria

• 1. Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are pregnant or breastfeeding.
• 2. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease).
• 3. Use of any other investigational agent in the last 30 days.
• 4. Absence of nasal symptoms.
• 5. Smoking.
• 6. URI at the time of screening.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Chicago

Overall Clinical Trial Officials and Contacts

Ro M Naclerio, MD Principal Investigator University of Chicago  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00618332

Study ID Number: 15624B

ClinicalTrials.gov Identifier: NCT00618332

Health Authority: United States: Institutional Review Board