Clinical trial NCT00626366: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Sinusitis
Keywords: Nasal Spray
Nasal Drop
Intranasal Medication
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2008-02-29
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: To Measure the Distribution of Nasal Sprays and Drops.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: ENT Specialist PC of Omaha
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Erin K O'Brien, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nebraska
name: Donald Leopold, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.