Chronic Frontal Rhinosinusitis Clinical Trial
Official title:
Effectiveness of Budesonide Nasal Instillation in a Vertex-to-floor Position in Chronic Rhinosinusitis Patients Underwent Endoscopic Frontal Sinus Surgery: a Randomized, Controlled Trial.
| Verified date | August 2016 |
| Source | Khon Kaen University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Thailand: Thai Clinical Trial Registry |
| Study type | Interventional |
o Chronic rhinosinusitis is one of the most common health issue affected American population. Surgery plays an important role in the patients who failed the medical treatment. The most difficult location to be operated endoscopically is the frontal sinus. Frontal sinus is also found to be one of the most common sinus for residual and recurrence after the operation. Intranasal steroid seems to be one of the most beneficent post-sinus surgery cares. The topical therapy can be delivered by many approaches. According to the standard clinical practice guideline and recommendations, intranasal corticosteroid spray is suggested. The technique proved to have greater distribution than standard intranasal spray is instillation of steroid nose drops. The head position for instillation of steroid nose drops proven to have a greater access to olfactory cleft and frontal area is Vertex-to-floor position.
| Status | Active, not recruiting |
| Enrollment | 60 |
| Est. completion date | August 2017 |
| Est. primary completion date | August 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
Inclusion Criteria: - Chronic rhinosinusitis with frontal sinusitis patient - Age =12 - Post-frontal sinus surgery with frontal sinus opening>3mm - Satisfactory surgical technique: adequate sinus osteal drainage and mucosal sparing technique Exclusion Criteria: - Isolated frontal sinus surgery - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Thailand | King Chulalongkorn Memorial Hospital | Bangkok | |
| Thailand | Srinagarind Hospital | Khon Kaen |
| Lead Sponsor | Collaborator |
|---|---|
| Khon Kaen University |
Thailand,
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. — View Citation
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. — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
Halawi AM, Smith SS, Chandra RK. Chronic rhinosinusitis: epidemiology and cost. Allergy Asthma Proc. 2013 Jul-Aug;34(4):328-34. doi: 10.2500/aap.2013.34.3675. Review. — View Citation
Hardy JG, Lee SW, Wilson CG. Intranasal drug delivery by spray and drops. J Pharm Pharmacol. 1985 May;37(5):294-7. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Miller TR, Muntz HR, Gilbert ME, Orlandi RR. Comparison of topical medication delivery systems after sinus surgery. Laryngoscope. 2004 Feb;114(2):201-4. — View Citation
Musy PY, Kountakis SE. Anatomic findings in patients undergoing revision endoscopic sinus surgery. Am J Otolaryngol. 2004 Nov-Dec;25(6):418-22. — View Citation
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):53-9. doi: 10.4193/Rhin. — View Citation
* Note: There are 13 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Total Sinonasal outcome test (SNOT) 20 score (validated Thai version) | three months | Yes | |
| Secondary | Video-recorded nasal endoscope scoring: Modified Lund-Mackay Endoscopy Score(MLMES) | three months | Yes | |
| Secondary | Rhinological Sinonasal outcome test (SNOT) 20 score (validated Thai version) | three months | Yes |