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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02862509
First Posted: August 11, 2016
Last Update Posted: August 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Navarat Vatcharayothin, Khon Kaen University
  Purpose
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.

Condition Intervention Phase
Chronic Frontal Rhinosinusitis Vertex to Floor Position Drug: Budesonide nasal instillation Drug: Normal saline nasal instillation Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Navarat Vatcharayothin, Khon Kaen University:

Primary Outcome Measures:
  • Total Sinonasal outcome test (SNOT) 20 score (validated Thai version) [ Time Frame: three months ]

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

Estimated Enrollment: 60
Study Start Date: November 2015
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862509


Locations
Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Srinagarind Hospital
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
  More Information

Publications:

Responsible Party: Navarat Vatcharayothin, Principal Investigator, Khon Kaen University
ClinicalTrials.gov Identifier: NCT02862509     History of Changes
Other Study ID Numbers: HE581299
First Submitted: July 16, 2016
First Posted: August 11, 2016
Last Update Posted: August 19, 2016
Last Verified: August 2016

Keywords provided by Navarat Vatcharayothin, Khon Kaen University:
Post-frontal sinus operation chronic rhinosinusitis patients
Budesonide nasal instillation
Vertex to floor position

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists