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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide via MAD | Experimental | 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. |
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| Budesonide via Sinus Rinse Bottle | Active Comparator | Budesonide via Sinus Rinse Bottle is the most commonly used delivery method. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mucosal Atomization Device (MAD) | Device | The use of pulmicort via MAD once a day for a total of 30 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cosyntropin testing and blood work for quantification of plasma budesonide and plasma cortisol. | Participants will be followed for 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Amin R Javer, MD, FRCSC, FARS | St. Paul's Hospital, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ENT Clinic, St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15224630 | Background | Lund VJ, Black JH, Szabo LZ, Schrewelius C, Akerlund A. Efficacy and tolerability of budesonide aqueous nasal spray in chronic rhinosinusitis patients. Rhinology. 2004 Jun;42(2):57-62. | |
| 19289711 | Background | Sachanandani NS, Piccirillo JF, Kramper MA, Thawley SE, Vlahiotis A. The effect of nasally administered budesonide respules on adrenal cortex function in patients with chronic rhinosinusitis. Arch Otolaryngol Head Neck Surg. 2009 Mar;135(3):303-7. doi: 10.1001/archoto.2008.555. |
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| Budesonide via Nasal Syringe | Device | The use of budesonide via Sinus Irrigation Bottle will be once a day for 30 days. |
|
| 10518847 | Background | Scott MB, Skoner DP. Short-term and long-term safety of budesonide inhalation suspension in infants and young children with persistent asthma. J Allergy Clin Immunol. 1999 Oct;104(4 Pt 2):200-9. doi: 10.1016/s0091-6749(99)70062-x. |
| 19128710 | Background | Bhalla RK, Payton K, Wright ED. Safety of budesonide in saline sinonasal irrigations in the management of chronic rhinosinusitis with polyposis: lack of significant adrenal suppression. J Otolaryngol Head Neck Surg. 2008 Dec;37(6):821-5. |
| 18585575 | Background | Kanowitz SJ, Batra PS, Citardi MJ. Topical budesonide via mucosal atomization device in refractory postoperative chronic rhinosinusitis. Otolaryngol Head Neck Surg. 2008 Jul;139(1):131-6. doi: 10.1016/j.otohns.2008.03.009. |
| 24449682 | Derived | Thamboo A, Manji J, Szeitz A, Santos RD, Hathorn I, Gan EC, Alsaleh S, Javer AR. The safety and efficacy of short-term budesonide delivered via mucosal atomization device for chronic rhinosinusitis without nasal polyposis. Int Forum Allergy Rhinol. 2014 May;4(5):397-402. doi: 10.1002/alr.21280. Epub 2014 Jan 21. |