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

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Budesonide Nasal Instillation in a Vertex-to-floor Position in Chronic Rhinosinusitis Patients Underwent Endoscopic Frontal Sinus Surgery: a Randomized, Controlled Trial.

Conditions
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Chronic Frontal Rhinosinusitis, Vertex to Floor Position

Intervention / Treatment
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* Drug: Budesonide nasal instillation
* Drug: Normal saline nasal instillation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide nasal instillation<br>budesonide(0.5mg/2ml) 1 respule plus normal saline solution 120ml instilled in vertex to floor position daily | Drug: Budesonide nasal instillation<br> <br> |
| Placebo Comparator: Normal saline nasal instillation<br>Normal saline solution instilled in vertex to floor position daily | Drug: Normal saline nasal instillation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sinonasal outcome test (SNOT) 20 score (validated Thai version) |  | three months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-frontal sinus operation chronic rhinosinusitis patients, Budesonide nasal instillation, Vertex to floor position