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

September 21, 2023 updated by: University of Nebraska
The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • ENT Specialist PC of Omaha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nasal spray
This arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses.
Radiation: Sinus CT Scan
Subjects will undergo a Xoran miniCAT scan of their sinuses
Drug: Omnipaque 240 Contrast Solution
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
Experimental: Nasal drop
This arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.
Radiation: Sinus CT Scan
Subjects will undergo a Xoran miniCAT scan of their sinuses
Drug: Omnipaque 240 mg I/mL
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Erin K O'Brien, MD, University of Nebraska
  • Study Chair: Donald Leopold, MD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2008

Primary Completion (Actual)

January 9, 2009

Study Completion (Actual)

January 9, 2009

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

February 20, 2008

First Posted (Estimated)

February 29, 2008

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0498-07-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Sinusitis

Clinical Trials on Sinus CT Scan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe