NCT00361439

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
4 years until next milestone

Results Posted

Study results publicly available

August 23, 2012

Completed
Last Updated

February 28, 2014

Status Verified

January 1, 2014

Enrollment Period

2.1 years

First QC Date

August 4, 2006

Results QC Date

July 20, 2012

Last Update Submit

January 27, 2014

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • 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

    2 weeks

Secondary Outcomes (3)

  • Change From Baseline in Total Nasal Symptom Score at 2 Weeks

    baseline and 2 weeks

  • Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks

    baseline and 2 weeks

  • Change From Baseline in Percentage of Eosinophils at 2 Weeks

    baseline and 2 weeks

Study Arms (2)

Mometasone

ACTIVE COMPARATOR

Mometasone intranasal steroid therapy daily for 2 weeks

Drug: Mometasone

Placebo

PLACEBO COMPARATOR

2 puffs of placebo spray in each nostril once daily

Drug: Placebo

Interventions

MometasoneDRUG

2 puffs in each nostril once daily of nasal spray

Also known as: Nasonex
Mometasone
PlaceboDRUG

2 puffs in each nostril once daily of nasal spray

Placebo

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • 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.

    PMID: 20819468DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Limitations and Caveats

Early termination due to slow accrual

Results Point of Contact

Title
Jayant Pinto, MD
Organization
University of Chicago
jpinto@surgery.bsd.uchicago.edu
773-702-6727

Study Officials

  • Jayant M Pinto, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2006

First Posted

August 8, 2006

Study Start

August 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

February 28, 2014

Results First Posted

August 23, 2012

Record last verified: 2014-01

Locations

US(1)