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

Chronic Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626366
• Other study ID #: 0498-07-FB
• Status: Completed
• Phase: N/A
• Start date: March 12, 2008
• Est. completion date: January 9, 2009

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 9, 2009
• Est. primary completion date: January 9, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Sinusitis
• Sinusitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	ENT Specialist PC of Omaha	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (7)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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