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

August 4, 2006
August 8, 2006
July 20, 2012
August 23, 2012
February 28, 2014
August 2006
September 2008   (Final data collection date for primary outcome measure)
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
Nasal inflammation
Complete list of historical versions of study NCT00361439 on Archive Site
  • 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.
  • 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.
  • 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.

  • Symptoms
  • Parameters of nasal physiology
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Not Provided
Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis
Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis

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.

Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Seasonal Allergic Rhinitis
  • Drug: Mometasone
    2 puffs in each nostril once daily of nasal spray
    Other Name: Nasonex
  • Drug: Placebo
    2 puffs in each nostril once daily of nasal spray
  • Active Comparator: Mometasone
    Mometasone intranasal steroid therapy daily for 2 weeks
    Intervention: Drug: Mometasone
  • Placebo Comparator: Placebo
    2 puffs of placebo spray in each nostril once daily
    Intervention: Drug: Placebo
Sivam A, Jeswani S, Reder L, Wang J, DeTineo M, Taxy J, Baroody FM, Naclerio RM, Pinto JM. Olfactory cleft inflammation is present in seasonal allergic rhinitis and is reduced with intranasal steroids. Am J Rhinol Allergy. 2010 Jul-Aug;24(4):286-90. doi: 10.2500/ajra.2010.24.3478.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2008
September 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 59 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
14757A (P04908)
IRB #14757A
Not Provided
Not Provided
University of Chicago
University of Chicago
Principal Investigator: Jayant M Pinto, MD University of Chicago
University of Chicago
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP