Comparing Budesonide Via MAD or INSI Prospective Cohort Study

• Status: Not yet recruiting
• Trial end date: 2021-02-03
• Target enrollment: 0
• Participant gender: All

Summary

Chronic Rhinosinusitis (CRS) is a common disorder in North America, affecting more than 31 million people annually. Common therapy for CRS includes intranasal corticosteroids (INCS) such as budesonide. At our centre , the current practice is to administer budesonide two ways: the mucosal atomization device (MAD), which is a nasal spray or impregnated budesonide in nasal saline irrigation (INSI), which is a nasal rinse. Our study aims to see which method of administering budesonide has the best treatment outcomes after sinus surgery. This study will follow patients over a six-month period of time.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Paul's Hospital, Canada
• Treatments: Budesonide

Criteria

Inclusion Criteria:

• Patients aged between 19 years and above

• Patients with chronic or recurrent sinusitis (as defined by the American Academy of Otolaryngology) with nasal polyposis or allergic fungal rhinosinusitis

• Patients with an upcoming primary sinus surgery or a revision sinus surgery

• Patients being prescribed INCS for the first time following Functional Endoscopic Sinus Surgery (FESS)

Exclusion Criteria:

• 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 that are not adherent to budesonide via MAD/INSI treatment

• Patients who are pregnant or breastfeeding