title: Growth velocity reduced with once-daily fluticasone furoate nasal spray in prepubescent children with perennial allergic rhinitis.
abstract: BACKGROUND
  The effect of fluticasone furoate nasal spray (FFNS) on growth in prepubescent children has not been evaluated.
  
  
  OBJECTIVE
  To characterize the difference in mean prepubescent growth velocities, as determined by stadiometry, between patients treated continuously for 1 year with FFNS 110 mcg once daily and placebo nasal spray.
  
  
  METHODS
  This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group 76-week safety study. Nasal symptom assessments were used as a measure of adherence. Eligible patients were ages 5 to <8.5 years at screening and had at least a 1-year clinical history and diagnosis of perennial allergic rhinitis, including a positive skin test or specific IgE to an appropriate perennial allergen within the past year.
  
  
  RESULTS
  One hundred eighty-six patients in the FFNS group and 187 patients in the placebo group completed the entire 52-week treatment period. During treatment, the least squares mean growth velocity was 5.19 cm/y for the FFNS group and 5.46 cm/y for the placebo group; mean difference, -0.270 cm/y (95% CI, -0.48 to -0.06 cm/y). Other safety assessments, including 24-hour urinary cortisol excretion, were comparable between the treatment groups. Daily reflective total nasal symptom scores declined similarly in both the FFNS and placebo groups.
  
  
  CONCLUSIONS
  Once-daily treatment with FFNS over 52 weeks in prepubescent children resulted in a small reduction in growth velocity compared with placebo. Clinicians will need to balance the reduction in growth observed with FFNS to its potential for clinical benefit.
authors.affiliation: Respiratory Research and Development, GlaxoSmithKline, Research Triangle Park, NC. Electronic address: laurie.a.lee@gsk.com.
authors.forename: Laurie A
authors.initials: LA
authors.lastname: Lee
authors.affiliation: Department of Otolaryngology Carolina Research, Orangeburg, SC.
authors.forename: Richard
authors.initials: R
authors.lastname: Sterling
authors.affiliation: Allergy and Respiratory Research Unit, Fundacion CIDEA, Buenos Aires, Argentina.
authors.forename: Jorge
authors.initials: J
authors.lastname: Máspero
authors.affiliation: Respiratory Research and Development, GlaxoSmithKline, Research Triangle Park, NC.
authors.forename: Diane
authors.initials: D
authors.lastname: Clements
authors.affiliation: Respiratory Research and Development, GlaxoSmithKline, Research Triangle Park, NC.
authors.forename: Anna
authors.initials: A
authors.lastname: Ellsworth
authors.affiliation: Pediatric Research Unit, Kolding Hospital, Kolding, Denmark.
authors.forename: Soren
authors.initials: S
authors.lastname: Pedersen
mesh_terms: D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D056667:Biometric Identification; D002648:Child; D002675:Child, Preschool; D005260:Female; D000068298:Fluticasone; D005500:Follow-Up Studies; D006128:Growth / Q000187:drug effects; D006801:Humans; D006854:Hydrocortisone / Q000652:urine; D007073:Immunoglobulin E / Q000097:blood; D008297:Male; D055118:Medication Adherence; D059085:Nasal Sprays; D011627:Puberty; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D012882:Skin Tests
chemical_list: D000730:Androstadienes; D059085:Nasal Sprays; D007073:Immunoglobulin E; D000068298:Fluticasone; D006854:Hydrocortisone
keywords: 24-Hour urinary cortisol; Children; Intranasal corticosteroid; Placebo controlled; Randomized clinical trial; Stadiometry