Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis

Study Overview
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Brief Summary
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People with allergies frequently complain of a loss or reduction in the sense of smell. In this study, the investigators 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.

Official Title
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Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Mometasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females between 18 and 59 years of age. Seasonal allergic rhinitis by clinical history, with symptoms of impaired olfaction. Positive skin or RAST test to allergen. Symptoms of olfactory dysfunction. No significant history of chronic sinusitis. Exclusion Criteria: Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are breastfeeding. 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). Use of any other investigational agent in the last 30 days. Absence of olfactory or nasal symptoms. Use of medications that may affect olfaction. Medical conditions that may affect olfaction. Smoking. URI at the time of screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mometasone<br>Mometasone intranasal steroid therapy daily for 2 weeks | Drug: Mometasone<br>* 2 puffs in each nostril once daily of nasal spray<br>* Other names: Nasonex;|
| Placebo Comparator: Placebo<br>2 puffs of placebo spray in each nostril once daily | Drug: Placebo<br>* 2 puffs in each nostril once daily of nasal spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological Findings | Number of eosinophils per high-powered field (HPF) in olfactory biopsy taken after 2 weeks of study treatment (higher values indicate greater inflammation); average of three HPF reported | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Total Nasal Symptom Score at 2 Weeks | A decrease in scores between visits signifies an improvement in nasal symptoms. The total nasal symptom score can range from 0 to 27. | baseline and 2 weeks | 
| Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks | An increase between visits indicates improved nasal airflow. | baseline and 2 weeks | 
| Change From Baseline in Percentage of Eosinophils at 2 Weeks | A decrease between visits signifies a reduction in inflammation. Calculated from cytology specimens obtained by lavage. | baseline and 2 weeks |