cAMP (Cyclic Adenosine Monophosphate) Levels in the Nose

Not Applicable

Completed

• Conditions: Olfactory Disorder
• Interventions: Other: saline nasal irrigation

• Registration Number: NCT01332825
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-07
• Study First Submitted QC: 2011-04-08
• Study First Posted: 2011-04-11
• Primary Completion: 2011-10
• Study Completion: 2012-12
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal olfaction	saline nasal irrigation	normal olfaction, randomized to saline nasal irrigation for 7 days

Primary Outcome Measures

Name	Time	Method
UPSIT	7 days	validated, scratch and sniff smell identification test

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States