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

NCT ID: NCT00626366

Last Updated: 2023-09-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-12

Study Completion Date

2009-01-09

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Sinusitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Sinus CT Scan

Intervention Type RADIATION

Subjects will undergo a Xoran miniCAT scan of their sinuses

Omnipaque 240 Contrast Solution

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Sinus CT Scan

Intervention Type RADIATION

Subjects will undergo a Xoran miniCAT scan of their sinuses

Omnipaque 240 mg I/mL

Intervention Type DRUG

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

Interventions

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Sinus CT Scan

Subjects will undergo a Xoran miniCAT scan of their sinuses

Intervention Type RADIATION

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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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contrast enhancement contrast enhancement

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erin K O'Brien, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Donald Leopold, MD

Role: STUDY_CHAIR

University of Nebraska

Locations

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ENT Specialist PC of Omaha

Omaha, Nebraska, United States

Site Status

Countries

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United States

References

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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. doi: 10.1016/j.otohns.2005.08.024.

Reference Type RESULT
PMID: 16360518 (View on PubMed)

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. doi: 10.1097/00005537-200208000-00013.

Reference Type RESULT
PMID: 12172251 (View on PubMed)

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. doi: 10.1097/01.mlg.0000149463.95950.c5.

Reference Type RESULT
PMID: 15564850 (View on PubMed)

Boatsman JE, Calhoun KH, Ryan MW. Relationship between rhinosinusitis symptoms and mucociliary clearance time. Otolaryngol Head Neck Surg. 2006 Mar;134(3):491-3. doi: 10.1016/j.otohns.2005.10.045.

Reference Type RESULT
PMID: 16500451 (View on PubMed)

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

Reference Type RESULT
PMID: 15224630 (View on PubMed)

Aukema AA, Fokkens WJ. Chronic rhinosinusitis: management for optimal outcomes. Treat Respir Med. 2004;3(2):97-105. doi: 10.2165/00151829-200403020-00004.

Reference Type RESULT
PMID: 15182211 (View on PubMed)

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. doi: 10.1016/j.otohns.2005.07.039.

Reference Type RESULT
PMID: 16274802 (View on PubMed)

Other Identifiers

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0498-07-FB

Identifier Type: -

Identifier Source: org_study_id

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