title: Efficacy and safety of beclomethasone dipropionate nasal aerosol in children with perennial allergic rhinitis.
abstract: BACKGROUND
  Beclomethasone dipropionate (BDP) nasal aerosol (non-aqueous) is approved for management of seasonal and perennial allergic rhinitis (PAR) in adolescents and adults.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of BDP nasal aerosol at 80 μg/day in children with PAR.
  
  
  METHODS
  This 12-week, phase 3, double-blinded, placebo-controlled, parallel-group study randomized 547 children (4-11 years old) with PAR to once-daily BDP nasal aerosol at 80 μg/day or placebo. The primary end point was change from baseline in average morning and evening reflective total nasal symptom score (rTNSS) during the first 6 weeks of treatment in patients 6 to 11 years old. Changes from baseline in average morning and evening instantaneous TNSS (iTNSS) in children 6 to 11 years old and average rTNSS and iTNSS in children 4 to 11 years old were assessed during the first 6 weeks of treatment.
  
  
  RESULTS
  Improvements were significantly greater with BDP nasal aerosol than with placebo during the first 6 weeks of treatment in children 6 to 11 years old in average morning and evening rTNSS and iTNSS (mean treatment difference -0.66 [P = .002] and -0.58 [P = .004], respectively). Improvements in average morning and evening rTNSS and iTNSS also were significantly greater in patients 4 to 11 years receiving BDP nasal aerosol than with placebo during the first 6 weeks of treatment (P = .002 and P = .004, respectively). Similar improvements were seen during 12 weeks of treatment. The safety profile of BDP nasal aerosol was comparable to that of placebo.
  
  
  CONCLUSIONS
  The BDP nasal aerosol at 80 μg/day in children 4 to 11 years old was well tolerated and effective in controlling nasal symptoms of PAR.
  
  
  BACKGROUND
  www.clinicaltrials.gov, identifier NCT01783548.
authors.affiliation: Allergy and Asthma Associates of Southern California, Mission Viejo, California. Electronic address: weberger@uci.edu.
authors.forename: William E
authors.initials: WE
authors.lastname: Berger
authors.affiliation: Biogenics Research Institute, San Antonio, Texas.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Jacobs
authors.affiliation: Allergy Asthma Research Institute, Waco, Texas.
authors.forename: Niran J
authors.initials: NJ
authors.lastname: Amar
authors.affiliation: Teva Branded Pharmaceutical Products R&D, Inc, Frazer, Pennsylvania.
authors.forename: Sudeesh K
authors.initials: SK
authors.lastname: Tantry
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: Calvin J
authors.initials: CJ
authors.lastname: Small
mesh_terms: D000280:Administration, Inhalation; D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D001507:Beclomethasone / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D059085:Nasal Sprays; D011788:Quality of Life / Q000523:psychology; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy* / Q000276:immunology / Q000503:physiopathology / Q000523:psychology; D016896:Treatment Outcome
chemical_list: D018926:Anti-Allergic Agents; D059085:Nasal Sprays; D001507:Beclomethasone