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

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Budesonide Spray Via Mucosal Atomization Device on the Hypothalamic-Pituitary Axis

Conditions
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Chronic Rhinosinusitis

Intervention / Treatment
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* Device: Mucosal Atomization Device (MAD)
* Device: Budesonide via Nasal Syringe


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide via MAD<br>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. | Device: Mucosal Atomization Device (MAD)<br>* The use of pulmicort via MAD once a day for a total of 30 days.<br>|
| Active Comparator: Budesonide via Sinus Rinse Bottle<br>Budesonide via Sinus Rinse Bottle is the most commonly used delivery method. | Device: Budesonide via Nasal Syringe<br>* The use of budesonide via Sinus Irrigation Bottle will be once a day for 30 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosyntropin testing and blood work for quantification of plasma budesonide and plasma cortisol. |  | Participants will be followed for 30 days. | 

Secondary Outcome Measures

| Outcome Measure | 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. |