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

Sponsor:	University of Nebraska
Information provided by:	University of Nebraska
ClinicalTrials.gov Identifier:	NCT00626366

Purpose

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.

Condition	Intervention
Chronic Sinusitis	Radiation: Sinus CT Scan Drug: Omnipaque 240 Contrast Solution Drug: Omnipaque 240 mg I/mL

Study Type:	Interventional
Study Design:	Non-Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Single Group Assignment
Official Title:	Distribution of Topical Nasal Medication Within the Nasal Cavity and Sinuses by Radiographic Comparison

Resource links provided by NLM:

MedlinePlus related topics: Nuclear Scans Sinusitis

Drug Information available for: Iohexol

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:

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

Estimated Enrollment:	8
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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.	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.
2: 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.	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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626366

Contacts

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

Locations

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

Sponsors and Collaborators

University of Nebraska

Investigators

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

More Information

Publications:

Senocak D, Senocak M, Bozan S. Sinonasal distribution of topically applied particles: computerized tomographic detection and the effects of topical decongestion. Otolaryngol Head Neck Surg. 2005 Dec;133(6):944-8.

Olson DE, Rasgon BM, Hilsinger RL Jr. Radiographic comparison of three methods for nasal saline irrigation. Laryngoscope. 2002 Aug;112(8 Pt 1):1394-8.

Wormald PJ, Cain T, Oates L, Hawke L, Wong I. A comparative study of three methods of nasal irrigation. Laryngoscope. 2004 Dec;114(12):2224-7.

Boatsman JE, Calhoun KH, Ryan MW. Relationship between rhinosinusitis symptoms and mucociliary clearance time. Otolaryngol Head Neck Surg. 2006 Mar;134(3):491-3.

Lund VJ, Black JH, Szabó LZ, Schrewelius C, Akerlund A. Efficacy and tolerability of budesonide aqueous nasal spray in chronic rhinosinusitis patients. Rhinology. 2004 Jun;42(2):57-62.

Aukema AA, Fokkens WJ. Chronic rhinosinusitis: management for optimal outcomes. Treat Respir Med. 2004;3(2):97-105. Review.

Cannady SB, Batra PS, Citardi MJ, Lanza DC. Comparison of delivery of topical medications to the paranasal sinuses via "vertex-to-floor" position and atomizer spray after FESS. Otolaryngol Head Neck Surg. 2005 Nov;133(5):735-40.

Responsible Party:	University of Nebraska Medical Center ( Erin O'Brien MD )
Study ID Numbers:	498-07-FB
Study First Received:	February 20, 2008
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00626366 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Nebraska:

Nasal Spray
Nasal Drop
Intranasal Medication

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

Paranasal Sinus Diseases
Chronic Disease
Sinusitis
Nose Diseases

ClinicalTrials.gov processed this record on November 25, 2009