Clinical trial NCT01405339: Budesonide Application Via Mucosal Atomization Device as a Treatment for Chronic Rhinosinusitis When Utilized as a Topical Nasal Steroid Spray
Official title: The Effect of Budesonide Spray Via Mucosal Atomization Device on the Hypothalamic-Pituitary Axis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Rhinosinusitis
Lead sponsor: St. Paul's Hospital, Canada
Sponsor class: OTHER
First posted: 2011-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Cosyntropin testing and blood work for quantification of plasma budesonide and plasma cortisol.
timeFrame: Participants will be followed for 30 days.
Secondary outcomes:
measure: SNOT-22 questionnaire to measure subjective perspective.
timeFrame: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: ENT Clinic, St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: St. Paul's Hospital, Canada
name: Amin R Javer, MD, FRCSC, FARS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.