Budesonide Application Via Mucosal Atomization Device as a Treatment for Chronic Rhinosinusitis When Utilized as a Topical Nasal Steroid Spray

Phase 1

Completed

• Conditions: Chronic Rhinosinusitis
• Interventions: Device: Mucosal Atomization Device (MAD); Device: Budesonide via Nasal Syringe

• Registration Number: NCT01405339
• Lead Sponsor: St. Paul's Hospital, Canada

Brief Summary

Budesonide, a steroid subtype, has been used as an adjunctive treatment for chronic rhinosinusitis as a topical nasal steroid spray. The current standard of care at St. Paul's Sinus Centre is to administer budesonide via the Mucosal Atomization Device (MAD). It is believed that the MAD is a better device than the standard nasal lavage because its fine mist enhances absorption and improves bioavailability. No studies have been done to determine if enhanced absorption and improved bioavailability of budesonide via MAD could potentially affect the hypothalamic-pituitary-adrenal (HPA) axis, resulting in the suppression of our own body's production of natural steroids.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Study Start: 2011-08
• Primary Completion: 2013-05
• Study Completion: 2014-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-07
• Last Update Posted: 2014-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 19 years of age or older
• Diagnosed with CRS with or without polyps
• Awaiting for Functional Endoscopic Sinus Surgery
• Give consent on their own

Exclusion Criteria

Concurrent or recent use (within the past 30 days) of systemic corticosteroids

• History of pituitary disease

• Morbid obesity (body mass index [calculated as weight in kilograms divided by height in meters squared]

• Concurrent or recent use of medications that accelerate the clearance of cortisol:

  o Such as dilantin, rifampin, amphetamines, or lithium carbonate

• Concurrent use of medications that interfere with the production of cortisol:

  o Such as ketoconazole, amphotericin B, bupropion, Echinacea, fluoroquinolones, itraconazole, licorice

• Use of oral contraception

• Use of female or male hormone therapy

• Known hypersensitivity to cortisol, corticotropin, or cosyntropin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Budesonide via MAD	Mucosal Atomization Device (MAD)	The current standard of care at St. Paul's Sinus Centre is to administer budesonide via the Mucosal Atomization Device (MAD). Its believed that MAD is a better device than the standard nasal lavage (Budesonide diluted in saline and delivered via Nasal Irrigation Bottle)because its fine mist and higher concentration enhances absorption and improves bioavailability.
Budesonide via Sinus Rinse Bottle	Budesonide via Nasal Syringe	Budesonide via Sinus Rinse Bottle is the most commonly used delivery method.

Primary Outcome Measures

Name	Time	Method
Cosyntropin testing and blood work for quantification of plasma budesonide and plasma cortisol.	Participants will be followed for 30 days.

Secondary Outcome Measures

Name	Time	Method
SNOT-22 questionnaire to measure subjective perspective.	Participants will be followed for the duration of post op standard of care, an expected average of 6 months.

Trial Locations

Locations (1)

ENT Clinic, St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada