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
  Purpose

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 Intervention Phase
Seasonal Allergic Rhinitis
Drug: Mometasone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.



Enrollment: 17
Study Start Date: August 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361439

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Schering-Plough
Investigators
Principal Investigator: Jayant M Pinto, MD University of Chicago
  More Information

No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00361439     History of Changes
Other Study ID Numbers: 14757A (P04908), IRB #14757A
Study First Received: August 4, 2006
Results First Received: July 20, 2012
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone furoate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 22, 2014