Effectiveness of Budesonide Nasal Instillation in a Vertex-to-floor Position
Primary Purpose
Chronic Frontal Rhinosinusitis, Vertex to Floor Position
Status
Unknown status
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Budesonide nasal instillation
Normal saline nasal instillation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Frontal Rhinosinusitis focused on measuring Post-frontal sinus operation chronic rhinosinusitis patients, Budesonide nasal instillation, Vertex to floor position
Eligibility Criteria
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
Sites / Locations
- King Chulalongkorn Memorial Hospital
- Srinagarind Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Budesonide nasal instillation
Normal saline nasal instillation
Arm Description
budesonide(0.5mg/2ml) 1 respule plus normal saline solution 120ml instilled in vertex to floor position daily
Normal saline solution instilled in vertex to floor position daily
Outcomes
Primary Outcome Measures
Total Sinonasal outcome test (SNOT) 20 score (validated Thai version)
Secondary Outcome Measures
Video-recorded nasal endoscope scoring: Modified Lund-Mackay Endoscopy Score(MLMES)
Rhinological Sinonasal outcome test (SNOT) 20 score (validated Thai version)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02862509
Brief Title
Effectiveness of Budesonide Nasal Instillation in a Vertex-to-floor Position
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Frontal Rhinosinusitis, Vertex to Floor Position
Keywords
Post-frontal sinus operation chronic rhinosinusitis patients, Budesonide nasal instillation, Vertex to floor position
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Budesonide nasal instillation
Arm Type
Experimental
Arm Description
budesonide(0.5mg/2ml) 1 respule plus normal saline solution 120ml instilled in vertex to floor position daily
Arm Title
Normal saline nasal instillation
Arm Type
Placebo Comparator
Arm Description
Normal saline solution instilled in vertex to floor position daily
Intervention Type
Drug
Intervention Name(s)
Budesonide nasal instillation
Intervention Type
Drug
Intervention Name(s)
Normal saline nasal instillation
Primary Outcome Measure Information:
Title
Total Sinonasal outcome test (SNOT) 20 score (validated Thai version)
Time Frame
three months
Secondary Outcome Measure Information:
Title
Video-recorded nasal endoscope scoring: Modified Lund-Mackay Endoscopy Score(MLMES)
Time Frame
three months
Title
Rhinological Sinonasal outcome test (SNOT) 20 score (validated Thai version)
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Srinagarind Hospital
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
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PubMed Identifier
23883597
Citation
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Effectiveness of Budesonide Nasal Instillation in a Vertex-to-floor Position
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