Effectiveness of Budesonide Nasal Instillation in a Vertex-to-floor Position
NCT ID: NCT02862509
Last Updated: 2016-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2015-11-30
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Budesonide nasal instillation
budesonide(0.5mg/2ml) 1 respule plus normal saline solution 120ml instilled in vertex to floor position daily
Budesonide nasal instillation
Normal saline nasal instillation
Normal saline solution instilled in vertex to floor position daily
Normal saline nasal instillation
Interventions
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Budesonide nasal instillation
Normal saline nasal instillation
Eligibility Criteria
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Inclusion Criteria
* Age ≥12
* Post-frontal sinus surgery with frontal sinus opening\>3mm
* Satisfactory surgical technique: adequate sinus osteal drainage and mucosal sparing technique
Exclusion Criteria
* History of previous head and neck radiation
* Previous nasal or sinus operation
* Clinically significant deviated nasal septum
* History of paranasal sinus tumor
* Known immunocompromised Host
* History of budesonide allergy
* Cannot provide full flexion of the neck (cannot perform vertex-to-floor position)
* Post-randomization exclusion: Pathologic invasive fungal infection
12 Years
ALL
No
Sponsors
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Khon Kaen University
OTHER
Responsible Party
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Navarat Vatcharayothin
Principal Investigator
Locations
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King Chulalongkorn Memorial Hospital
Bangkok, Bangkok, Thailand
Srinagarind Hospital
Khon Kaen, Changwat Khon Kaen, Thailand
Countries
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References
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Halawi AM, Smith SS, Chandra RK. Chronic rhinosinusitis: epidemiology and cost. Allergy Asthma Proc. 2013 Jul-Aug;34(4):328-334. doi: 10.2500/aap.2013.34.3675.
Blackwell DL, Lucas JW, Clarke TC. Summary health statistics for U.S. adults: national health interview survey, 2012. Vital Health Stat 10. 2014 Feb;(260):1-161.
Bhattacharyya N. Incremental health care utilization and expenditures for chronic rhinosinusitis in the United States. Ann Otol Rhinol Laryngol. 2011 Jul;120(7):423-7. doi: 10.1177/000348941112000701.
Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000.
Grobler A, Weitzel EK, Buele A, Jardeleza C, Cheong YC, Field J, Wormald PJ. Pre- and postoperative sinus penetration of nasal irrigation. Laryngoscope. 2008 Nov;118(11):2078-81. doi: 10.1097/MLG.0b013e31818208c1.
Musy PY, Kountakis SE. Anatomic findings in patients undergoing revision endoscopic sinus surgery. Am J Otolaryngol. 2004 Nov-Dec;25(6):418-22. doi: 10.1016/j.amjoto.2004.06.002.
Harvey RJ, Goddard JC, Wise SK, Schlosser RJ. Effects of endoscopic sinus surgery and delivery device on cadaver sinus irrigation. Otolaryngol Head Neck Surg. 2008 Jul;139(1):137-42. doi: 10.1016/j.otohns.2008.04.020.
Miller TR, Muntz HR, Gilbert ME, Orlandi RR. Comparison of topical medication delivery systems after sinus surgery. Laryngoscope. 2004 Feb;114(2):201-4. doi: 10.1097/00005537-200402000-00004.
Harvey RJ, Debnath N, Srubiski A, Bleier B, Schlosser RJ. Fluid residuals and drug exposure in nasal irrigation. Otolaryngol Head Neck Surg. 2009 Dec;141(6):757-61. doi: 10.1016/j.otohns.2009.09.006.
Hardy JG, Lee SW, Wilson CG. Intranasal drug delivery by spray and drops. J Pharm Pharmacol. 1985 May;37(5):294-7. doi: 10.1111/j.2042-7158.1985.tb05069.x.
Aoki FY, Crowley JC. Distribution and removal of human serum albumin-technetium 99m instilled intranasally. Br J Clin Pharmacol. 1976 Oct;3(5):869-78. doi: 10.1111/j.1365-2125.1976.tb00640.x.
Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.
Snidvongs K, Dalgorf D, Kalish L, Sacks R, Pratt E, Harvey RJ. Modified Lund Mackay Postoperative Endoscopy Score for defining inflammatory burden in chronic rhinosinusitis. Rhinology. 2014 Mar;52(1):53-59. doi: 10.4193/Rhino13.056.
Other Identifiers
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HE581299
Identifier Type: -
Identifier Source: org_study_id
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