Efficacy of Budesonide Via Delayed Release vs Immediate Release
Status:
Not yet recruiting
Trial end date:
2022-02-28
Target enrollment:
Participant gender:
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.