Overview

This trial is active, not recruiting.

Conditions chronic frontal rhinosinusitis, vertex to floor position
Treatments budesonide nasal instillation, normal saline nasal instillation
Phase phase 2
Sponsor Khon Kaen University
Start date November 2015
End date August 2017
Trial size 60 participants
Trial identifier NCT02862509, HE581299

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
budesonide(0.5mg/2ml) 1 respule plus normal saline solution 120ml instilled in vertex to floor position daily
budesonide nasal instillation
(Placebo Comparator)
Normal saline solution instilled in vertex to floor position daily
normal saline nasal instillation

Primary Outcomes

Measure
Total Sinonasal outcome test (SNOT) 20 score (validated Thai version)
time frame: three months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 12 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Khon Kaen University.