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cAMP (Cyclic Adenosine Monophosphate) Levels in the Nose

NCT ID: NCT01332825

Last Updated: 2013-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Olfactory Disorder

Keywords

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olfaction smell dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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olfactory dysfunction

subjects diagnosed with olfactory dysfunction

Group Type NO_INTERVENTION

No interventions assigned to this group

normal olfaction, no saline

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

Group Type NO_INTERVENTION

No interventions assigned to this group

normal olfaction

normal olfaction, randomized to saline nasal irrigation for 7 days

Group Type OTHER

saline nasal irrigation

Intervention Type OTHER

subjects irrigate with nasal saline daily for one week

Interventions

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saline nasal irrigation

subjects irrigate with nasal saline daily for one week

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Greg Davis

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Greg E Davis, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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39352-A

Identifier Type: -

Identifier Source: org_study_id