Clinical trial NCT01332825: cAMP (Cyclic Adenosine Monophosphate) Levels in the Nose
Official title: cAMP Levels in the Nose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Olfactory Disorder
Keywords: olfaction
smell dysfunction
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2011-04-11
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: UPSIT
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Greg E Davis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: