Effectiveness of Budesonide Nasal Instillation in a Vertex-to-floor Position

Phase 2

• Conditions: Chronic Frontal Rhinosinusitis; Vertex to Floor Position
• Interventions: Drug: Budesonide nasal instillation; Drug: Normal saline nasal instillation

• Registration Number: NCT02862509
• Lead Sponsor: Khon Kaen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-07-16
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-07
• Study First Posted: 2016-08-11
• Last Update Submitted: 2016-08-18
• Last Update Posted: 2016-08-19
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Budesonide nasal instillation	Budesonide nasal instillation	budesonide(0.5mg/2ml) 1 respule plus normal saline solution 120ml instilled in vertex to floor position daily
Normal saline nasal instillation	Normal saline nasal instillation	Normal saline solution instilled in vertex to floor position daily

Primary Outcome Measures

Name	Time	Method
Total Sinonasal outcome test (SNOT) 20 score (validated Thai version)	three months

Secondary Outcome Measures

Name	Time	Method
Rhinological Sinonasal outcome test (SNOT) 20 score (validated Thai version)	three months
Video-recorded nasal endoscope scoring: Modified Lund-Mackay Endoscopy Score(MLMES)	three months

Trial Locations

Locations (2)

Srinagarind Hospital; 🇹🇭 Khon Kaen, Thailand

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand