title: No hypothalamic-pituitary-adrenal function effect with beclomethasone dipropionate nasal aerosol, based on 24-hour serum cortisol in pediatric allergic rhinitis.
abstract: BACKGROUND
  Intranasal corticosteroids are the mainstay of allergic rhinitis (AR) treatment. Their potential to suppress the hypothalamic-pituitary-adrenal axis should be evaluated, especially after long-term daily use in children.
  
  
  OBJECTIVE
  To evaluate the effects of treatment with non-aqueous beclomethasone dipropionate (BDP) nasal aerosol on hypothalamic-pituitary-adrenal axis function in children with perennial AR.
  
  
  METHODS
  In this double-blinded, placebo-controlled, parallel-group study, patients (6-11 years old) with perennial AR were randomized (2:1) to BDP nasal aerosol at 80 μg/day (n = 67) or placebo (n = 32). The primary end point was change from baseline in 24-hour serum cortisol (SC) weighted mean for BDP nasal aerosol and placebo after 6 weeks of treatment, which was analyzed in the per-protocol population.
  
  
  RESULTS
  The per-protocol population included 97 patients (BDP nasal aerosol, n = 66; placebo, n = 31). Baseline geometric mean SC weighted mean values were similar in the 80-μg/day BDP nasal aerosol and placebo groups (5.97 and 6.47 μg/dL, respectively). After 6 weeks' treatment, geometric mean values were 6.19 and 7.13 μg/dL, respectively, with no decrease from baseline in either group. Geometric mean SC ratio of BDP nasal aerosol at 80 μg/day to placebo was 0.91 (95% confidence interval 0.81-1.03), indicating predefined noninferiority. SC concentration-time profiles were similar for the placebo and 80-μg/day BDP nasal aerosol groups at baseline and week 6. BDP nasal aerosol at 80 μg/day was generally well tolerated.
  
  
  CONCLUSIONS
  In pediatric patients with perennial AR, 24-hour SC profiles were comparable for BDP nasal aerosol and placebo, indicating that once-daily BDP nasal aerosol treatment did not significantly affect hypothalamic-pituitary-adrenal axis function.
  
  
  BACKGROUND
  ClinicalTrials.gov; NCT01697956.
authors.affiliation: Central Texas Health Research, New Braunfels, Texas. Electronic address: fchampel@aol.com.
authors.forename: Frank C
authors.initials: FC
authors.lastname: Hampel
authors.affiliation: Sneeze, Wheeze, and Itch Associates, LLC, Normal, Illinois.
authors.forename: Nicholas A
authors.initials: NA
authors.lastname: Nayak
authors.affiliation: Georgia Allergy and Respiratory, Atlanta, Georgia.
authors.forename: Nathan
authors.initials: N
authors.lastname: Segall
authors.affiliation: Teva Branded Pharmaceutical Products R&D, Inc, Frazer, Pennsylvania.
authors.forename: Calvin J
authors.initials: CJ
authors.lastname: Small
authors.affiliation: Teva Branded Pharmaceutical Products R&D, Inc, Frazer, Pennsylvania.
authors.forename: Jiang
authors.initials: J
authors.lastname: Li
authors.affiliation: Teva Branded Pharmaceutical Products R&D, Inc, Frazer, Pennsylvania.
authors.forename: Sudeesh K
authors.initials: SK
authors.lastname: Tantry
mesh_terms: D000280:Administration, Inhalation; D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D001507:Beclomethasone / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000097:blood*; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects / Q000502:physiology; D008297:Male; D059085:Nasal Sprays; D010913:Pituitary-Adrenal System / Q000187:drug effects / Q000502:physiology; D012221:Rhinitis, Allergic, Perennial / Q000097:blood / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology; D016896:Treatment Outcome
chemical_list: D018926:Anti-Allergic Agents; D059085:Nasal Sprays; D001507:Beclomethasone; D006854:Hydrocortisone