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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02862509

Enrollment

Registered

2016-08-11

Start date

2015-11-30

Completion date

2017-08-31

Last updated

2016-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Frontal Rhinosinusitis, Vertex to Floor Position

Keywords

Post-frontal sinus operation chronic rhinosinusitis patients, Budesonide nasal instillation, Vertex to floor position

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.

Interventions

DRUGBudesonide nasal instillation

DRUGNormal saline nasal instillation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026