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Clinical Trials/NCT01332825
NCT01332825CompletedNot Applicable

cAMP Levels in the Nose

University of Washington2 sites in 1 country41 target enrollmentStarted: March 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
41
Locations
2
Primary Endpoint
UPSIT

Study Overview

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.

Detailed Description

The investigators will recruit 40 subjects: 10 with olfactory dysfunction and 30 with normal olfaction. The normal olfaction group will be randomized (15-15)to either daily saline nasal irrigation for one week or no irrigation. Normal olfaction subjects will be seen for two visits, olfactory dysfunction for one. All subjects will complete an UPSIT (smell identification test)and a co-morbidity form. All subjects will have a brief nasal exam and then have nasal cells collected by means of a curette on one side and a cytobrush on the other. All subjects will receive Afrin and lidocaine, to improve visualization and for comfort during cell collection. Subjects will then complete a Comfort Scale related to the methods of cell collection. Normal olfaction subjects randomized to nasal irrigation will receive instructions on how to do it and the irrigation results will be collected for analysis along with the nasal cells. At their return visit, normal olfaction subjects will repeat the UPSIT and the comfort scale--all normal olfaction subjects will have a repeat cell collection. Subjects randomized to nasal irrigation will also complete a transition scale which asks if they feel the irrigation made a difference in their sense of smell. Subjects are compensated for time with a gift card.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

UPSIT

Time Frame: 7 days

validated, scratch and sniff smell identification test

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Greg Davis

Assistant Professor

University of Washington

Study Sites (2)

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