title: Intranasal triamcinolone and growth velocity.
abstract: BACKGROUND
  Inadequate designs and conflicting results from previous studies prompted the US Food and Drug Administration to publish guidelines for the design of clinical trials evaluating the effects of orally inhaled and intranasal corticosteroids on the growth of children. This study conformed to these guidelines to evaluate the effect of triamcinolone acetonide aqueous nasal spray (TAA-AQ) on the growth of children with perennial allergic rhinitis (PAR).
  
  
  METHODS
  This randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluated the effect of once-daily TAA-AQ (110 μg) on the growth velocity (GV) of children aged 3-9 years with PAR by using stadiometry at baseline (4-6 months), during treatment (12 months), and at follow-up (2 months). Hypothalamus-pituitary-adrenal (HPA) axis function was assessed by measuring urinary cortisol levels. Details of adverse events were recorded.
  
  
  RESULTS
  Of 1078 subjects screened, 299 were randomized, and 216 completed the study (placebo, 107; TAA-AQ, 109). In the primary analysis (modified intent-to-treat: placebo, 133; TAA-AQ, 134), least-squares mean GV during treatment was lower in the TAA-AQ group (5.65 cm/year) versus placebo (6.09 cm/year). The difference (-0.45 cm/year; 95% confidence interval: -0.78 to -0.11; P = .01), although clinically nonsignificant, was evident within 2 months of treatment and stabilized thereafter. At follow-up, the GV approached baseline (6.70 cm/year) in the TAA-AQ group (6.59 cm/year) and decreased slightly in the placebo group (5.89 cm/year vs 6.06 cm/year at baseline). No HPA axis suppression was observed.
  
  
  CONCLUSIONS
  By using rigorous Food and Drug Administration-recommended design elements, this study detected a small, statistically significant effect of TAA-AQ on the GV of children with PAR.
authors.affiliation: Allegheny General Hospital, Allegheny Health Network, Pittsburgh, Pennsylvania; Temple University School of Medicine, Philadelphia, Pennsylvania; dskoner@wpahs.org.
authors.forename: David P
authors.initials: DP
authors.lastname: Skoner
authors.affiliation: Division of Basic and Clinical Immunology, Department of Medicine, University of California, Irvine, Irvine, California;
authors.forename: William E
authors.initials: WE
authors.lastname: Berger
authors.affiliation: Department of Pediatrics, Thomas Jefferson University, Philadelphia, Pennsylvania; Asthma and Allergy Associates, Upland, Pennsylvania; and.
authors.forename: Sandra M
authors.initials: SM
authors.lastname: Gawchik
authors.affiliation: Medical Affairs and.
authors.forename: Akbar
authors.initials: A
authors.lastname: Akbary
authors.affiliation: Clinical and Science Operation Departments, Sanofi US, Bridgewater, New Jersey.
authors.forename: Chunfu
authors.initials: C
authors.lastname: Qiu
mesh_terms: D000281:Administration, Intranasal; D000284:Administration, Oral; D001827:Body Height / Q000187:drug effects*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006854:Hydrocortisone / Q000652:urine; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects; D016018:Least-Squares Analysis; D008297:Male; D010913:Pituitary-Adrenal System / Q000187:drug effects; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D014222:Triamcinolone Acetonide / Q000008:administration & dosage* / Q000009:adverse effects*
chemical_list: D014222:Triamcinolone Acetonide; D006854:Hydrocortisone
keywords: HPA axis; growth velocity; intranasal corticosteroid; perennial allergic rhinitis; triamcinolone acetonide aqueous nasal spray