Sinusitis Clinical Trial
Official title:
The Long-Term Safety of Budesonide Via Mucosal Atomization Device and Impregnated Nasal Saline Irrigations for Patients With Chronic Rhinosinusitis - A Prospective Double Cohort Study.
Chronic Rhinosinusitis (CRS) is a common disorder of the nose. The current practice at St Paul's Sinus Centre is to prescribe budesonide via the mucosal atomization device or impregnated saline irrigation. Both have shown to be a safe method of administration. A previous study demonstrated a 6% elevation in intraocular pressure and 3% prevalence of asymptomatic AdrenoCorticoTropic Hormone-Axis (ACTH) suppression. However, a baseline measurement was not conducted to ascertain the correlation of these findings with the medication. Therefore, the investigators aim to conduct baseline measurements of IntraOcular Pressure (IOP), ACTH-axis function, and Dual Energy X-ray Absorptiometry (DEXA) scan and obtaining regular measurements of these variables within a 12-month period to further ascertain these previous findings.
Purpose:
The purpose of this study is to assess the long-term effects of budesonide via MAD (Mucosal
Atomization Device) or INSI (Intranasal Saline Irrigation) on intraocular pressure, ACTH-axis
function, and bone-density.
Hypothesis:
Budesonide delivered via MAD or INSI will be safe in the long-term (> 12 months) demonstrated
objectively via IOP, ACTH stimulation test, and DEXA scan.
Justification:
The safety profile of both MAD and INSI has been widely studied in the literature. Although
both modalities are generally considered safe, several studies have demonstrated asymptomatic
hypothalamic-pituitary-adrenal axis (HPAA) suppression when used in the long-term. A
cross-sectional study at St Paul's Sinus Centre, found 3% of study participants on long-term
maintenance treatment via MAD to have asymptomatic HPAA suppression. However, the
cross-sectional study design limited the ability to ascertain the timeline for this adverse
event.
Although the recent cross-sectional study at St Paul Sinus Centre was the first to study the
long-term effects of budesonide via the MAD in CRS patients, it did not include baseline
levels of HPAA function and IOP levels which served as a limitation to ascertaining the
timeline of the aforementioned adverse events. Additionally, there is currently limited data
on the effects of INCS on bone function in the setting of CRS treatment. Therefore, this
study aims to prospectively assess the long-term effect of high-dose nasal corticosteroids
(i.e. INSI and MAD) in CRS patients. The study design will obtain baseline measurements of
ACTH function, IOP measurement, and a DEXA scan to identify and describe the timeline of
adverse events should they develop during the 12-month study period. By determining the
impact of nasal corticosteroids on these outcomes, potential improvements can be made in the
safety monitoring practices of otolaryngologists. This may include more frequent monitoring
of intraocular pressure, Bone Mineral Density (BMD), and HPAA-axis function in at-risk
populations, development of budesonide tapering guidelines, and improved screening of
patient-reported adverse events. Overall, the investigators hope the results from this study
will be a step forward in the development of screening guidelines for monitoring patients on
long-term IntraNasal CorticoSteroids (INCS) therapy.
Primary Objective:
To assess long-term safety (> 12 months) of budesonide delivered via MAD or INSI as measured
objectively via IOP, ACTH stimulation test, and DEXA scan.
Research Design:
A Prospective Double-Cohort Study
Statistical Analysis:
Descriptive statistics will be used to analyze the baseline characteristic data and the data
from the administered surveys and objective findings of ACTH stimulation test, IOP
measurement, and DEXA scans. In addition, rigorous statistical analysis will be conducted on
the Likert scale-based SinoNasal Outcome Test (SNOT-22) and EuroQuol health-related quality
of life surveys (EQ-5D-5L). These analyses will include cross-tabulations (Pearson's chi
square test) and confidence interval calculations. Due to the variations in baseline
intraocular pressure measurements, the investigators will calculate an adjusted difference
instead of absolute values.
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