title: Efficacy and safety of beclomethasone dipropionate nasal aerosol in pediatric patients with seasonal allergic rhinitis.
abstract: BACKGROUND
  Aerosolized intranasal corticosteroid formulations are desirable for many patients with allergic rhinitis (AR), especially children, who wish to avoid the "wet feeling" and "drip down the throat" associated with aqueous formulations. Beclomethasone dipropionate (BDP) hydrofluoroalkane nasal aerosol has been shown to be safe and effective in adolescents and adults with AR.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of BDP nasal aerosol in pediatric patients with moderate to severe seasonal AR.
  
  
  METHODS
  In this double-blinded, placebo-controlled study, children (6-11 years of age) with seasonal AR were randomized to once-daily treatment with BDP nasal aerosol 80 μg (n = 239) or 160 μg (n = 242) or placebo (n = 234). The primary end point was change from baseline in average morning and evening reflective total nasal symptom score over the 2-week treatment period.
  
  
  RESULTS
  Treatment with BDP nasal aerosol showed significantly greater improvements in average morning and evening reflective total nasal symptom score vs placebo (80 μg, -0.71; 160 μg, -0.76; P < .001 for the 2 comparisons). Similarly, significantly greater improvements in average morning and evening instantaneous total nasal symptom score were seen with BDP nasal aerosol vs placebo (80 μg, -0.63; 160 μg, -0.73; P < .001 for the 2 comparisons). The incidence of adverse events from BDP nasal aerosol was comparable to that from placebo.
  
  
  CONCLUSIONS
  BDP nasal aerosol (80 or 160 μg/d) provided significant and clinically meaningful nasal symptom relief and an established overall safety profile similar to that of placebo, suggesting that it is an effective and well-tolerated treatment option for pediatric patients with moderate to severe seasonal AR.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT012073190.
authors.affiliation: William Storms Allergy Clinic, Colorado Springs, Colorado. Electronic address: wstorms@stormsallergy.com.
authors.forename: William W
authors.initials: WW
authors.lastname: Storms
authors.forename: Nathan
authors.initials: N
authors.lastname: Segall
authors.forename: Lyndon E
authors.initials: LE
authors.lastname: Mansfield
authors.forename: Niran J
authors.initials: NJ
authors.lastname: Amar
authors.forename: Leith
authors.initials: L
authors.lastname: Kelley
authors.forename: Yu
authors.initials: Y
authors.lastname: Ding
authors.forename: Sudeesh K
authors.initials: SK
authors.lastname: Tantry
mesh_terms: D000281:Administration, Intranasal; D000336:Aerosols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D001507:Beclomethasone / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D059085:Nasal Sprays; D010919:Placebos; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000336:Aerosols; D018927:Anti-Asthmatic Agents; D059085:Nasal Sprays; D010919:Placebos; D001507:Beclomethasone