Status:
WITHDRAWN
Efficacy of Budesonide Via Delayed Release vs Immediate Release
Lead Sponsor:
St. Paul's Hospital, Canada
Conditions:
Chronic Rhinosinusitis (Diagnosis)
Eligibility:
All Genders
19+ years
Phase:
EARLY_PHASE1
Brief Summary
The aim of this study is to compare the efficacy of intranasal budesonide administration with lying head back position and a 5 mins time to release of medication (5MR) compared to 1 min time to releas...
Detailed Description
Objective To compare the efficacy of 1 minute versus 5 minutes time to release of budesonide with lying head back position following administration via mucosal atomization device (MAD). Hypothesis ...
Eligibility Criteria
Inclusion
- Patients aged between 19 years and above
- Patients with chronic or recurrent sinusitis (as defined by the American Academy of Otolaryngology) with or without nasal polyposis or allergic fungal rhinosinusitis.
- Patients currently on budesonide or being prescribed budesonide for the first time
- Minimum Modified Lund Kennedy score of 2.
Exclusion
- Individuals unable to understand the purpose, methods and conduct of this study
- Patients unwilling to provide informed consent
- Are immuno-compromised, and have impairment in mucociliary function (e.g., cystic fibrosis, Kartagener syndrome)
- Have autoimmune diseases affecting the upper airway (eg Systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis etc)
- Have sinonasal tumors
- Patients with a history of pituitary disease
- Patients with a known hypersensitivity to cortisol, corticotropin, or cosyntropin
- Recent use of systemic corticosteroids such as prednisone (within last 3 months)
- Patients who are pregnant or breastfeeding
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04476628
Start Date
February 1 2021
End Date
February 28 2022
Last Update
July 11 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.