cAMP (Cyclic Adenosine Monophosphate) Levels in the Nose

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01332825
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : December 12, 2013
Information provided by (Responsible Party):
Greg Davis, University of Washington

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.

Condition or disease Intervention/treatment Phase
Olfactory Disorder Other: saline nasal irrigation Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: cAMP Levels in the Nose
Study Start Date : March 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. UPSIT [ Time Frame: 7 days ]
    validated, scratch and sniff smell identification test

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01332825

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

Responsible Party: Greg Davis, Assistant Professor, University of Washington Identifier: NCT01332825     History of Changes
Other Study ID Numbers: 39352-A
First Posted: April 11, 2011    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013

Keywords provided by Greg Davis, University of Washington:
smell dysfunction