Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00361439
Recruitment Status : Terminated (Study stopped early due to slow accrual.)
First Posted : August 8, 2006
Results First Posted : August 23, 2012
Last Update Posted : February 28, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Mometasone Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis
Study Start Date : August 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Mometasone
Mometasone intranasal steroid therapy daily for 2 weeks
Drug: Mometasone
2 puffs in each nostril once daily of nasal spray
Other Name: Nasonex
Placebo Comparator: Placebo
2 puffs of placebo spray in each nostril once daily
Drug: Placebo
2 puffs in each nostril once daily of nasal spray

Primary Outcome Measures :
  1. Histological Findings [ Time Frame: 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 :
  1. Change From Baseline in Total Nasal Symptom Score at 2 Weeks [ Time Frame: 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.

  2. Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks [ Time Frame: baseline and 2 weeks ]
    An increase between visits indicates improved nasal airflow.

  3. Change From Baseline in Percentage of Eosinophils at 2 Weeks [ Time Frame: baseline and 2 weeks ]

    A decrease between visits signifies a reduction in inflammation.

    Calculated from cytology specimens obtained by lavage.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00361439

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Jayant M Pinto, MD University of Chicago

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Chicago Identifier: NCT00361439     History of Changes
Other Study ID Numbers: 14757A (P04908)
IRB #14757A
First Posted: August 8, 2006    Key Record Dates
Results First Posted: August 23, 2012
Last Update Posted: February 28, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents