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

NCT00626366 | Completed Results DMC

• 1 other identifier: 0498-07-FB
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Sinusitis

Keywords

Nasal Spray; Nasal Drop; Intranasal Medication

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months

Study Arms (2)

Nasal spray

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; Drug: Omnipaque 240 Contrast Solution

Nasal drop

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; Drug: Omnipaque 240 mg I/mL

Interventions

Sinus CT Scan RADIATION

Subjects will undergo a Xoran miniCAT scan of their sinuses

Nasal drop; Nasal spray

Omnipaque 240 Contrast Solution DRUG

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

Also known as: contrast enhancement

Nasal spray

Omnipaque 240 mg I/mL DRUG

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

Also known as: contrast enhancement

Nasal drop

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult able to perform activities of daily living

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

ENT Specialist PC of Omaha

Omaha, Nebraska, 68114, United States

Location

Related Publications (7)

• 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.

  PMID: 16360518 RESULT

• 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.

  PMID: 12172251 RESULT

• 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.

  PMID: 15564850 RESULT

• 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.

  PMID: 16500451 RESULT

• 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.

  PMID: 15224630 RESULT

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

  PMID: 15182211 RESULT

• 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.

  PMID: 16274802 RESULT

MeSH Terms

Interventions

Iohexol

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Erin K O'Brien
• Organization: University of Nebraska Medical Center

irbora@unmc.edu

402-559-6463

Study Officials

• Erin K O'Brien, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

• Donald Leopold, MD

  University of Nebraska

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: February 29, 2008
• Study Start: March 12, 2008
• Primary Completion: January 9, 2009
• Study Completion: January 9, 2009
• Last Updated: September 28, 2023
• Results First Posted: August 15, 2019

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)