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

August 18, 2016 updated by: Navarat Vatcharayothin, Khon Kaen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Budesonide nasal instillation
budesonide(0.5mg/2ml) 1 respule plus normal saline solution 120ml instilled in vertex to floor position daily
Drug: Budesonide nasal instillation
Placebo Comparator: Normal saline nasal instillation
Normal saline solution instilled in vertex to floor position daily
Drug: Normal saline nasal instillation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

July 16, 2016

First Submitted That Met QC Criteria

August 7, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE581299

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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