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

St. Paul's Hospital, Canada

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Rhinosinusitis

Treatments: Device: Budesonide via Nasal Syringe; Device: Mucosal Atomization Device (MAD)

Study type: Interventional

Funder types: Other

Identifiers

NCT01405339

PSMAD2011

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Budesonide via MAD

Experimental group

Description:

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.

Treatment:

Device: Mucosal Atomization Device (MAD)

Budesonide via Sinus Rinse Bottle

Active Comparator group

Description:

Budesonide via Sinus Rinse Bottle is the most commonly used delivery method.

Treatment:

Device: Budesonide via Nasal Syringe