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

Tracking Information

First Received Date ^ICMJE

February 20, 2008

Last Updated Date

February 20, 2008

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine the distribution of nasal sprays and drops. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Non-Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Single Group Assignment

Condition ^ICMJE

Chronic Sinusitis

Intervention ^ICMJE

Radiation: Sinus CT Scan
Drug: Omnipaque 240 Contrast Solution
Drug: Omnipaque 240 mg I/mL

Study Arms / Comparison Groups

Experimental: 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.
Experimental: 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.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2008

Estimated Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Kelli L Olechoski, BA	402-689-0767	kolechos@unmc.edu
Contact: Erin K O'Brien, MD	402-559-7777	eobrien@unmc.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00626366

Responsible Party

Erin O'Brien MD, University of Nebraska Medical Center

Study ID Numbers ^ICMJE

498-07-FB

Study Sponsor ^ICMJE

University of Nebraska

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Erin K O'Brien, MD	UNMC Department of Otolaryngology
Study Chair:	Donald Leopold, MD	UNMC Department of Otolaryngology

Information Provided By

University of Nebraska

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP