Back to resultsTreatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis
Primary Purpose
Seasonal Allergic Rhinitis
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mometasone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria: Males and females between 18 and 59 years of age. Seasonal allergic rhinitis by clinical history, with symptoms of impaired olfaction. Positive skin or RAST test to allergen. Symptoms of olfactory dysfunction. No significant history of chronic sinusitis. Exclusion Criteria: Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are breastfeeding. 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). Use of any other investigational agent in the last 30 days. Absence of olfactory or nasal symptoms. Use of medications that may affect olfaction. Medical conditions that may affect olfaction. Smoking. URI at the time of screening.
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Mometasone
Placebo
Arm Description
Mometasone intranasal steroid therapy daily for 2 weeks
2 puffs of placebo spray in each nostril once daily
Outcomes
Primary Outcome Measures
Histological Findings
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
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
An increase between visits indicates improved nasal airflow.
Change From Baseline in Percentage of Eosinophils at 2 Weeks
A decrease between visits signifies a reduction in inflammation.
Calculated from cytology specimens obtained by lavage.
Full Information
NCT ID
NCT00361439
First Posted
August 4, 2006
Last Updated
January 27, 2014
Sponsor
University of Chicago
Collaborators
Schering-Plough
1. Study Identification
Unique Protocol Identification Number
NCT00361439
Brief Title
Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis
Official Title
Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Terminated
Why Stopped
Study stopped early due to slow accrual.
Study Start Date
August 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Schering-Plough
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mometasone
Arm Type
Active Comparator
Arm Description
Mometasone intranasal steroid therapy daily for 2 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 puffs of placebo spray in each nostril once daily
Intervention Type
Drug
Intervention Name(s)
Mometasone
Other Intervention Name(s)
Nasonex
Intervention Description
2 puffs in each nostril once daily of nasal spray
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 puffs in each nostril once daily of nasal spray
Primary Outcome Measure Information:
Title
Histological Findings
Description
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
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Total Nasal Symptom Score at 2 Weeks
Description
A decrease in scores between visits signifies an improvement in nasal symptoms. The total nasal symptom score can range from 0 to 27.
Time Frame
baseline and 2 weeks
Title
Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks
Description
An increase between visits indicates improved nasal airflow.
Time Frame
baseline and 2 weeks
Title
Change From Baseline in Percentage of Eosinophils at 2 Weeks
Description
A decrease between visits signifies a reduction in inflammation.
Calculated from cytology specimens obtained by lavage.
Time Frame
baseline and 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males and females between 18 and 59 years of age.
Seasonal allergic rhinitis by clinical history, with symptoms of impaired olfaction.
Positive skin or RAST test to allergen.
Symptoms of olfactory dysfunction.
No significant history of chronic sinusitis.
Exclusion Criteria:
Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are breastfeeding.
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).
Use of any other investigational agent in the last 30 days.
Absence of olfactory or nasal symptoms.
Use of medications that may affect olfaction.
Medical conditions that may affect olfaction.
Smoking.
URI at the time of screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayant M Pinto, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20819468
Citation
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.
Results Reference
derived
Learn more about this trial
Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis
We'll reach out to this number within 24 hrs