cAMP (Cyclic Adenosine Monophosphate) Levels in the Nose

University of Washington

Status: Completed

Conditions: Olfactory Disorder

Treatments: Other: saline nasal irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT01332825

39352-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

41 participants in 3 patient groups

olfactory dysfunction

No Intervention group

Description:

subjects diagnosed with olfactory dysfunction

normal olfaction, no saline

No Intervention group

Description:

no smell dysfunction, not randomized to saline nasal irrigation for 7 days

normal olfaction

Other group

Description:

normal olfaction, randomized to saline nasal irrigation for 7 days

Treatment:

Other: saline nasal irrigation