NCT01332825

Brief Summary

The purpose of this study is to determine the normal distribution of nasal tissue cathelicidin antimicrobial peptides (cAMP) levels in subjects with normal smell and subjects with smell dysfunction. The investigators will also look at the effect of nasal saline irrigation on olfaction and cAMP levels and if nasal irrigation is capable of harvesting olfactory cilia. The investigators hypothesize that nasal saline will have no effect on olfaction and will be inadequate to harvest olfactory cilia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 12, 2013

Status Verified

December 1, 2013

Enrollment Period

7 months

First QC Date

April 7, 2011

Last Update Submit

December 11, 2013

Conditions

Olfactory Disorder

Keywords

olfactionsmell dysfunction

Outcome Measures

Primary Outcomes (1)

  • UPSIT

    validated, scratch and sniff smell identification test

    7 days

Study Arms (3)

olfactory dysfunction

NO INTERVENTION

subjects diagnosed with olfactory dysfunction

normal olfaction, no saline

NO INTERVENTION

no smell dysfunction, not randomized to saline nasal irrigation for 7 days

normal olfaction

OTHER

normal olfaction, randomized to saline nasal irrigation for 7 days

Other: saline nasal irrigation

Interventions

saline nasal irrigationOTHER

subjects irrigate with nasal saline daily for one week

normal olfaction

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal olfactory function cohort:
  • self-reported normal smell function
  • age greater than 18 years
  • Olfactory dysfunction cohort:
  • ICD9 diagnostic code for olfactory dysfunction
  • idiopathic olfactory dysfunction
  • age greater than 18 years

You may not qualify if:

  • allergy to lidocaine
  • active upper respiratory infection
  • previous nasal or sinus surgery
  • current tobacco use
  • unable to give consent due to language barrier, cognitive or medical issues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

AnosmiaOlfaction Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Greg E Davis, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 7, 2011

First Posted

April 11, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2011

Study Completion

December 1, 2012

Last Updated

December 12, 2013

Record last verified: 2013-12

Locations

US(1)