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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
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
July 16, 2016
Last Updated
August 18, 2016
Sponsor
Khon Kaen University
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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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23883597
Citation
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Effectiveness of Budesonide Nasal Instillation in a Vertex-to-floor Position

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