NCT01405339

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: St. Paul's Hospital, Canada · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Rhinosinusitis

Interventions

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

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-05-01
• Completion: 2014-01-01
• First posted: 2011-07-29
• Last updated: 2014-03-10

Locations

1 site across 1 country: Canada