Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-09-30

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.

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mometasone

Mometasone intranasal steroid therapy daily for 2 weeks

Group Type ACTIVE_COMPARATOR

Mometasone

Intervention Type DRUG

2 puffs in each nostril once daily of nasal spray

Placebo

2 puffs of placebo spray in each nostril once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 puffs in each nostril once daily of nasal spray

Interventions

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Mometasone

2 puffs in each nostril once daily of nasal spray

Intervention Type DRUG

Placebo

2 puffs in each nostril once daily of nasal spray

Intervention Type DRUG

Other Intervention Names

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Nasonex

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes