Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis

Phase 4

Terminated

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: Placebo; Drug: Mometasone

• Registration Number: NCT00361439
• Lead Sponsor: University of Chicago

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-04
• Study First Submitted QC: 2006-08-04
• Study First Posted: 2006-08-08
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2012-07-20
• Results First Submitted QC: 2012-07-20
• Results First Posted: 2012-08-23
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-27
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2 puffs of placebo spray in each nostril once daily
Mometasone	Mometasone	Mometasone intranasal steroid therapy daily for 2 weeks

Primary Outcome Measures

Name	Time	Method
Histological Findings	2 weeks	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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Percentage of Eosinophils at 2 Weeks	baseline and 2 weeks	A decrease between visits signifies a reduction in inflammation.; Calculated from cytology specimens obtained by lavage.
Change From Baseline in Total Nasal Symptom Score at 2 Weeks	baseline and 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.
Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks	baseline and 2 weeks	An increase between visits indicates improved nasal airflow.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States