cAMP (Cyclic Adenosine Monophosphate) Levels in the Nose

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT01332825

Collaborator

(none)

Enrollment

Location

Arms

21.1

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

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 :

Mar 1, 2011

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

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
Other: 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

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

Other: 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

Outcome Measures

Primary Outcome Measures

UPSIT [7 days]
validated, scratch and sniff smell identification test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Greg Davis, Assistant Professor, University of Washington

ClinicalTrials.gov Identifier:

NCT01332825

Other Study ID Numbers:

39352-A

First Posted:

Apr 11, 2011

Last Update Posted:

Dec 12, 2013

Last Verified:

Dec 1, 2013

Keywords provided by Greg Davis, Assistant Professor, University of Washington

olfaction

smell dysfunction

Study Results

No Results Posted as of Dec 12, 2013