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Completed

NCT Number: NCT00626366

Distribution of Topical Nasal Medication Within the Nasal Cavity and Sinuses by Radiographic Comparison

The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used.

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Key information

Conditions

Chronic Sinusitis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ENT Specialist PC of Omaha

Omaha, Nebraska, 68114, United States

About this study

The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used. The study hypothesizes that nasal drops will reach the frontonasal region more often than nasal sprays.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • adult able to perform activities of daily living

Exclusion criteria

  • signs or symptoms of acute or chronic paranasal sinus disease
  • history of sinus surgery
  • symptomatic deviated septum
  • active seasonal allergies
  • allergies to contrast
  • history of nasal polyposis
  • pregnant or breast feeding women
  • neck or back problems that would prevent a subject from kneeling on the floor and crouching over
  • currently taking metformin or amiodarone
  • students or stff under the direct supervision of the investigators
  • cognitive impairment
  • terminal illness

Treatment and study plan

Sinus CT Scan

Radiation

Subjects will undergo a Xoran miniCAT scan of their sinuses

Omnipaque 240 Contrast Solution

Drug

Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml.

Other names: contrast enhancement

Omnipaque 240 mg I/mL

Drug

Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.

Other names: contrast enhancement

Primary outcomes

  1. To Measure the Distribution of Nasal Sprays and Drops.

    Time frame: 2 months

    CT scan scored for distribution contrast delivered by nasal spray or drops within subsets in the nasal cavity. The sinonasal cavity was divided into twenty-one subsites on each side of the nasal cavity. The interpreters scored for the presence (1) or absence (0) of contrast from the nasal spray or nasal drops within each subsite. Left and right sides were interpreted separately for a possible total score of 0-42 for each CT scan.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 29, 2008
Registry last updated
Sep 28, 2023

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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