Budesonide Application Via Mucosal Atomization Device as a Treatment for Chronic Rhinosinusitis When Utilized as a Topical Nasal Steroid Spray
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|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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|