Impact of Topical Sinonasal Budesonide Irrigation on Hypothalamic-Pituitary-Adrenal Axis Function
Status:
Terminated
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
Chronic rhinosinusitis (CRS) is a complex inflammatory disease that is treated primarily with
sinus surgery and the long-term use of topical steroid therapy. Budesonide irrigation is a
common method of topical steroid treatment for these patients. However, the effects of
budesonide irrigation on the hypothalamic-pituitary-adrenal (HPA) axis in patients with CRS
following sinus surgery, is as of yet not defined. The objective of this study is to
determine if topical sinonasal budesonide steroid irrigation leads to acute recoverable
and/or long-term suppression of the HPA axis. Participants in this prospective cohort study
will have CRS and have recently undergone endoscopic sinus surgery. They will also have had
planned use of budesonide irrigations as their postoperative medical treatment. The acute
effects of this treatment on the HPA axis will be evaluated using serial serum cortisol
measurements both the day before and the day of the first budesonide irrigation. The
long-term effect of sinonasal budesonide irrigation will be evaluated using both a pre- and
post-treatment adrenocorticotropic hormone (ACTH) stimulation test as well as repeated urine
free cortisol levels over the length of the study. The results will determine the need for
additional steroids when patients stop treatment or with a physiologic stressful event.