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

Khon Kaen University

Status and phase: Unknown; Phase 2

Conditions: Chronic Frontal Rhinosinusitis; Vertex to Floor Position

Treatments: Drug: Budesonide nasal instillation; Drug: Normal saline nasal instillation

Study type: Interventional

Funder types: Other

Identifiers

NCT02862509

HE581299

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Budesonide nasal instillation

Experimental group

Description:

budesonide(0.5mg/2ml) 1 respule plus normal saline solution 120ml instilled in vertex to floor position daily

Treatment:

Drug: Budesonide nasal instillation

Normal saline nasal instillation

Placebo Comparator group

Description:

Normal saline solution instilled in vertex to floor position daily

Treatment:

Drug: Normal saline nasal instillation