Status:
COMPLETED
Budesonide Application Via Mucosal Atomization Device as a Treatment for Chronic Rhinosinusitis When Utilized as a Topical Nasal Steroid Spray
Lead Sponsor:
St. Paul's Hospital, Canada
Conditions:
Chronic Rhinosinusitis
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
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 admin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01405339
Start Date
August 1 2011
End Date
January 1 2014
Last Update
March 10 2014
Active Locations (1)
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1
ENT Clinic, St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6