Official Title: “Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis”

People with allergies frequently complain of a loss or reduction in the sense of smell.

In this study, we propose to perform a randomized, double blind, placebo controlled parallel study of subjects with nasal allergies and decreased smell to determine the effect of a treatment for allergies on the sense of smell.

Study Type: Interventional

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

Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

• Drug: mometasone nasal spray or placebo
  • 2 puffs in each nostril once daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • mometasone daily for 2 weeks
• Placebo Comparator: 2
  • 2 puffs of placebo spray once daily

Primary Measures

• histological findings
  • Time Frame: 2 weeks
    Safety Issue?: No

Secondary Measures

• Symptoms
  • Time Frame: 2 weeks
    Safety Issue?: No
• Parameters of nasal physiology
  • Time Frame: 2 weeks
    Safety Issue?: No

Inclusion Criteria:

• 1. Males and females between 18 and 59 years of age.
• 2. Seasonal allergic rhinitis by clinical history, with symptoms of impaired olfaction.
• 3. Positive skin or RAST test to allergen.
• 4. Symptoms of olfactory dysfunction.
• 5. No significant history of chronic sinusitis.

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 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 olfactory or nasal symptoms.
• 5. Use of medications that may affect olfaction.
• 6. Medical conditions that may affect olfaction.
• 7. Smoking.
• 8. 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: 59 Years

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

Lead Sponsor: University of Chicago

Overall Clinical Trial Officials and Contacts

Jayant M Pinto, MD Principal Investigator University of Chicago  

Overall Contact: Marcy deTineo, BSN 773-702-5889 mdetineo@surgery.bsd.uchicago.edu

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00361439

Study ID Number: 14757A (P04908)

ClinicalTrials.gov Identifier: NCT00361439

Health Authority: United States: Institutional Review Board