Budesonide Application Via Mucosal Atomization Device as a Treatment for Chronic Rhinosinusitis When Utilized as a Topical Nasal Steroid Spray
|ClinicalTrials.gov Identifier: NCT01405339|
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : March 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Chronic Rhinosinusitis||Device: Mucosal Atomization Device (MAD) Device: Budesonide via Nasal Syringe||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Budesonide Spray Via Mucosal Atomization Device on the Hypothalamic-Pituitary Axis|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||January 2014|
Experimental: Budesonide via MAD
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)
The use of pulmicort via MAD once a day for a total of 30 days.
Active Comparator: Budesonide via Sinus Rinse Bottle
Budesonide via Sinus Rinse Bottle is the most commonly used delivery method.
Device: Budesonide via Nasal Syringe
The use of budesonide via Sinus Irrigation Bottle will be once a day for 30 days.
- Cosyntropin testing and blood work for quantification of plasma budesonide and plasma cortisol. [ Time Frame: Participants will be followed for 30 days. ]
- SNOT-22 questionnaire to measure subjective perspective. [ Time Frame: Participants will be followed for the duration of post op standard of care, an expected average of 6 months. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405339
|Canada, British Columbia|
|ENT Clinic, St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Principal Investigator:||Amin R Javer, MD, FRCSC, FARS||St. Paul's Hospital, Canada|