The Effect of Budesonide Spray Via Mucosal Atomization Device on the Hypothalamic-Pituitary Axis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Rhinosinusitis
- Sponsor
- St. Paul's Hospital, Canada
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Cosyntropin testing and blood work for quantification of plasma budesonide and plasma cortisol.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Amin Javer
MD FRCSC FARS, Principal Investigator, Director of St Paul's Sinus Centre
St. Paul's Hospital, Canada
Eligibility Criteria
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
Outcomes
Primary Outcomes
Cosyntropin testing and blood work for quantification of plasma budesonide and plasma cortisol.
Time Frame: Participants will be followed for 30 days.
Secondary Outcomes
- 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.)