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

Primary Purpose

Chronic Sinusitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sinus CT Scan

Omnipaque 240 Contrast Solution

Omnipaque 240 mg I/mL

About this trial

This is an interventional other trial for Chronic Sinusitis focused on measuring Nasal Spray, Nasal Drop, Intranasal Medication

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

ENT Specialist PC of Omaha

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Nasal spray

Nasal drop

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

To Measure the Distribution of Nasal Sprays and Drops.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00626366

First Posted

February 20, 2008

Last Updated

September 21, 2023

Sponsor

University of Nebraska

1. Study Identification

Unique Protocol Identification Number

NCT00626366

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

March 12, 2008 (Actual)

Primary Completion Date

January 9, 2009 (Actual)

Study Completion Date

January 9, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Nebraska

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Sinusitis

Keywords

Nasal Spray, Nasal Drop, Intranasal Medication

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nasal spray

Arm Type

Experimental

Arm Description

Arm Title

Nasal drop

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Sinus CT Scan

Intervention Description

Subjects will undergo a Xoran miniCAT scan of their sinuses

Intervention Type

Drug

Intervention Name(s)

Omnipaque 240 Contrast Solution

Other Intervention Name(s)

contrast enhancement

Intervention Description

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

Intervention Name(s)

Omnipaque 240 mg I/mL

Other Intervention Name(s)

contrast enhancement

Intervention Description

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

Primary Outcome Measure Information:

Title

To Measure the Distribution of Nasal Sprays and Drops.

Description

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erin K O'Brien, MD

Organizational Affiliation

University of Nebraska

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Donald Leopold, MD

Organizational Affiliation

University of Nebraska

Official's Role

Study Chair

Facility Information:

Facility Name

ENT Specialist PC of Omaha

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

16360518

Citation

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.

Results Reference

result

PubMed Identifier

12172251

Citation

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.

Results Reference

result

PubMed Identifier

15564850

Citation

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.

Results Reference

result

PubMed Identifier

16500451

Citation

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.

Results Reference

result

PubMed Identifier

15224630

Citation

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.

Results Reference

result

PubMed Identifier

15182211

Citation

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

Results Reference

result

PubMed Identifier

16274802

Citation

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.

Results Reference

result

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

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