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Completed

NCT Number: NCT01332825

cAMP (Cyclic Adenosine Monophosphate) Levels in the Nose

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

saline nasal irrigation

Other

subjects irrigate with nasal saline daily for one week

Primary outcomes

  1. UPSIT

    Time frame: 7 days

    validated, scratch and sniff smell identification test

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

cAMP Levels in the Nose

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Apr 11, 2011
Registry last updated
Dec 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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