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cAMP (Cyclic Adenosine Monophosphate) Levels in the Nose

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Greg Davis, University of Washington
ClinicalTrials.gov Identifier:
NCT01332825
First received: April 7, 2011
Last updated: April 27, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Olfactory Disorder
 Other: saline nasal irrigation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: cAMP Levels in the Nose

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • UPSIT [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    validated, scratch and sniff smell identification test


Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: December 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: olfactory dysfunction
subjects diagnosed with olfactory dysfunction
No Intervention: normal olfaction, no saline
no smell dysfunction, not randomized to saline nasal irrigation for 7 days
normal olfaction
normal olfaction, randomized to saline nasal irrigation for 7 days
 Other: saline nasal irrigation
subjects irrigate with nasal saline daily for one week

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332825

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Greg E Davis, MD, MPH University of Washington
  More Information

No publications provided

Responsible Party: Greg Davis, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01332825     History of Changes
Other Study ID Numbers: 39352-A
Study First Received: April 7, 2011
Last Updated: April 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
olfaction
smell dysfunction

ClinicalTrials.gov processed this record on June 18, 2013