title: Safety of long-term high-volume sinonasal budesonide irrigations for chronic rhinosinusitis.
abstract: 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) minimum 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. Exclusion 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.
  
  
  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.
  
  
  CONCLUSIONS
  Outcomes from this study suggest that daily high-volume sinonasal budesonide irrigations fail to produce evidence of HPA axis suppression with prolonged courses lasting longer than 2 years.
authors.affiliation: Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Kristine A
authors.initials: KA
authors.lastname: Smith
authors.affiliation: Faculty of Medicine, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Gabrielle
authors.initials: G
authors.lastname: French
authors.affiliation: Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Bradford
authors.initials: B
authors.lastname: Mechor
authors.affiliation: Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Luke
authors.initials: L
authors.lastname: Rudmik
mesh_terms: D000328:Adult; D000368:Aged; D019819:Budesonide / Q000627:therapeutic use*; D002908:Chronic Disease; D015331:Cohort Studies; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D055556:Nasal Lavage; D056687:Off-Label Use; D010913:Pituitary-Adrenal System / Q000187:drug effects*; D012220:Rhinitis / Q000188:drug therapy*; D012852:Sinusitis / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D019819:Budesonide; D006854:Hydrocortisone
keywords: budesonide; chronic rhinosinusitis; corticosteroid; irrigations; medical therapy; safety; sinusitis; topical therapy