Efficacy of Budesonide Via Delayed Release vs Immediate Release

• Status: Not yet recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

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 release (1MR) in chronic rhinosinusitis patients (CRS). Participants will be instructed to administer via mucosal automatization device (MAD) with either of the two treatment approaches daily for 5 to 7 days per week and 8 weeks total. This is a crossover study design so each participants will be placed in the other treatment approach for an additional 8 weeks of treatment. Moreover, there will be a "washout" of 2 weeks after baseline assessment and before the first treatment, as well as a second "washout" of 2 weeks between the two treatment approaches. The participants will also complete study related procedures such as endoscopic evaluation, cultures, and two questionnaires throughout the study period. The investigators hypothesize that Budesonide delivered to the sinuses with a 5 minute time to release of medication will be more effective at decreasing inflammation when compared to a 1 minute time to release of medication after administration.

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

Details

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

Criteria

Inclusion Criteria:

1. Patients aged between 19 years and above

2. Patients with chronic or recurrent sinusitis (as defined by the American Academy of Otolaryngology) with or without nasal polyposis or allergic fungal rhinosinusitis.

3. Patients currently on budesonide or being prescribed budesonide for the first time

4. Minimum Modified Lund Kennedy score of 2.

Exclusion Criteria:

1. Individuals unable to understand the purpose, methods and conduct of this study

2. Patients unwilling to provide informed consent

3. Are immuno-compromised, and have impairment in mucociliary function (e.g., cystic fibrosis, Kartagener syndrome)

4. Have autoimmune diseases affecting the upper airway (eg Systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis etc)

5. Have sinonasal tumors

6. Patients with a history of pituitary disease

7. Patients with a known hypersensitivity to cortisol, corticotropin, or cosyntropin

8. Recent use of systemic corticosteroids such as prednisone (within last 3 months)

9. Patients who are pregnant or breastfeeding