cAMP (Cyclic Adenosine Monophosphate) Levels in the Nose

Olfactory Disorder Clinical Trial

Official title:

cAMP Levels in the Nose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332825
• Other study ID #: 39352-A
• Status: Completed
• Phase: N/A
• First received: April 7, 2011
• Last updated: December 11, 2013
• Start date: March 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Olfactory Disorder

Intervention

Other:
• saline nasal irrigation
subjects irrigate with nasal saline daily for one week

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UPSIT	validated, scratch and sniff smell identification test	7 days	No