Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2009 by University of Chicago. Recruitment status was Active, not recruiting

First Received on August 4, 2006. Last Updated on May 6, 2009 History of Changes

Sponsor:	University of Chicago
Collaborator:	Schering-Plough
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00361439

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 nasal spray or placebo	Phase IV

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:

MedlinePlus related topics: Allergy Hay Fever

Drug Information available for: Mometasone furoate

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

Histological findings [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Symptoms [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Parameters of nasal physiology [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	August 2006
Estimated Study Completion Date:	July 2009
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 mometasone daily for 2 weeks	Drug: mometasone nasal spray or placebo 2 puffs in each nostril once daily Other Name: Nasonex or placebo
Placebo Comparator: 2 2 puffs of placebo spray once daily	Drug: mometasone nasal spray or placebo 2 puffs in each nostril once daily Other Name: Nasonex or placebo

Eligibility

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

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.

Contacts and Locations

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):

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.

Responsible Party:	Jayant M. Pinto, MD, University ofChicago
ClinicalTrials.gov Identifier:	NCT00361439 History of Changes
Other Study ID Numbers:	14757A (P04908), IRB #14757A
Study First Received:	August 4, 2006
Last Updated:	May 6, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity

Immune System Diseases
Respiratory Tract Infections
Mometasone furoate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012