2016 Section 5 Green Book

Reprinted by permission of Int Forum Allergy Rhinol. 2016; 6(3):228-232.

OR I G I NAL ART I CLE

Safety of long-term high-volume sinonasal budesonide irrigations for chronic rhinosinusitis Kristine A. Smith, MD 1 , Gabrielle French, BSc 2 , Bradford Mechor, MD 1 and Luke Rudmik, MD, MSc 1

Results: A total of 35 patients fulfilled eligibility criteria and underwent HPA axis testing. Mean duration of budesonide sinonasal irrigation therapy use was 38.2 months (2.9 years). The mean ± standard deviation (SD) am serum cortisol was 431.2 ± 146.9 nmol/L (normal, 200 to 650 nmol/L). Subsequent cosyntropin stimulation tests, in indicated patients (n = 19), demonstrated no evidence of HPA axis suppression. Conclusion: Outcomes from this study suggest that daily high-volume sinonasal budesonide irrigations fail to pro- duce evidence of HPA axis suppression with prolonged courses lasting longer than 2 years. C 2016 ARS-AAOA, LLC. Key Words: chronic rhinosinusitis; sinusitis; medical therapy; safety; budesonide; topical therapy; corticosteroid; irrigations How to Cite this Article : Smith KA, French G, Mechor B, Rudmik L. Safety of long-term high-volume sinonasal budesonide irrigations for chronic rhinosinusitis. Int ForumAllergy Rhinol . 2016;6: 228–232. Common medical strategies generally include high-volume isotonic irrigations and topical intranasal corticosteroids, as well as systemic corticosteroids, antibiotics, leukotriene pathway modulators, and allergy control. 3 Adequate de- livery of topical intranasal corticosteroids continues to be one of the greatest barriers to decreasing sinonasal mu- cosal inflammation. 5 High-volume irrigation techniques have been shown to improve the delivery of topical medica- tions into the paranasal sinuses and this is the recommended approach for managing patients with CRS, especially those who have undergone endoscopic sinus surgery (ESS). 6–11 As such, the off-label use of budesonide respules mixed into high-volume saline irrigations has become a common main- tenance strategy during the management of CRS. However, given the off-label nature of this treatment, the safety pro- file has not been as rigorously defined compared to other U.S. Food and Drug Administration (FDA) approval low- volume metered-dose corticosteroid sprays. 12

Background: Off-label high-volume sinonasal budesonide irrigations are commonly used during the management of chronic rhinosinusitis (CRS). Although short-term use (4 to 8 weeks) has been demonstrated to be safe, the long-term effects on the hypothalamic-pituitary-adrenal (HPA) axis remain unclear. The objective of this study is to determine whether CRS patients using long-term (minimum greater than 12 months) budesonide sinonasal irrigations have evidence of HPA axis suppression. Methods: Patients with CRS being managed with high- volume sinonasal budesonide irrigations were recruited from 2 tertiary level rhinology clinics between March 2014 and July 2015. Inclusion criteria were as follows: (1) adult (age greater than 18 years); (2) guideline-based diagnosis of CRS; (3) previous endoscopic sinus surgery; (4) min- imum of twice daily high-volume sinonasal budesonide irrigation (concentration of 1 mg per irrigation; total daily dose of 2 mg); and (5) a minimum of 12-month duration. Ex- clusion criteria included systemic corticosteroid use within 3 months of HPA axis testing. The primary outcomes were morning (am) serum cortisol levels and, when indicated, cosyntropin stimulation levels.

C hronic rhinosinusitis (CRS) is a common inflammatory disease of the paranasal sinuses that affects approxi- mately 5% to 11% of the general population. 1,2 Main- tenance medical therapy is essential for successful long- term disease control in the majority of CRS patients. 3,4

1 Division of Otolaryngology–Head and Neck Surgery, Department of Surgery, University of Calgary, Calgary, Alberta, Canada; 2 Faculty of

Medicine, University of Calgary, Calgary, Alberta, Canada Correspondence to: Luke Rudmik, MD, MSc, Division of

Otolaryngology–Head and Neck Surgery, Department of Surgery, University of Calgary, Foothills Medical Centre, South Tower Suite 602, 1403 - 29th St. NW T2N 2T9, Calgary, Alberta, Canada; e-mail: lukerudmik@gmail.com Potential conflict of interest: None provided. Presented at the Annual ARS Meeting at the American Academy of Otolaryngology Meeting on September 25–26, 2015, in Dallas, TX. Received: 4 September 2015; Revised: 4 November 2015; Accepted: 29 November 2015 DOI: 10.1002/alr.21700 View this article online at wileyonlinelibrary.com.

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