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

Chronic Rhinosinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405339
• Other study ID #: PSMAD2011
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 26, 2011
• Last updated: March 7, 2014
• Start date: August 2011
• Est. completion date: January 2014

Study information

• Verified date: March 2014
• Source: St. Paul's Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Sinusitis

Intervention

Device:
• Mucosal Atomization Device (MAD)
The use of pulmicort via MAD once a day for a total of 30 days.
• Budesonide via Nasal Syringe
The use of budesonide via Sinus Irrigation Bottle will be once a day for 30 days.

Locations

Country	Name	City	State
Canada	ENT Clinic, St. Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
St. Paul's Hospital, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View 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. — View Citation

Lund VJ, Black JH, Szabó LZ, Schrewelius C, Akerlund A. Efficacy and tolerability of budesonide aqueous nasal spray in chronic rhinosinusitis patients. Rhinology. 2004 Jun;42(2):57-62. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cosyntropin testing and blood work for quantification of plasma budesonide and plasma cortisol.		Participants will be followed for 30 days.	No
Secondary	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.	No