Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis

The University of Chicago

Status and phase: Terminated; Phase 4

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Placebo; Drug: Mometasone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00361439

IRB #14757A

14757A (P04908)

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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17 participants in 2 patient groups, including a placebo group

Mometasone

Active Comparator group

Description:

Mometasone intranasal steroid therapy daily for 2 weeks

Treatment:

Drug: Mometasone

Placebo

Placebo Comparator group

Description:

2 puffs of placebo spray in each nostril once daily

Treatment:

Drug: Placebo