Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis

This study has been terminated.
(Study stopped early due to slow accrual.)
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00361439
First received: August 4, 2006
Last updated: January 27, 2014
Last verified: January 2014

August 4, 2006
January 27, 2014
August 2006
September 2008   (final data collection date for primary outcome measure)
Histological Findings [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
  • Change From Baseline in Total Nasal Symptom Score at 2 Weeks [ Time Frame: baseline and 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    An increase between visits indicates improved nasal airflow.
  • Change From Baseline in Percentage of Eosinophils at 2 Weeks [ Time Frame: baseline and 2 weeks ] [ Designated as safety issue: No ]

    A decrease between visits signifies a reduction in inflammation.

    Calculated from cytology specimens obtained by lavage.

  • Symptoms
  • Parameters of nasal physiology
Not Provided
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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
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.
Both
18 Years to 59 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00361439
14757A (P04908), IRB #14757A
No
University of Chicago
University of Chicago
Schering-Plough
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