title: Efficacy and safety of budesonide administered by pressurized metered-dose inhaler in children with asthma.
abstract: BACKGROUND
  Budesonide is approved for delivery using a nebulized solution and dry-powder inhaler, but its use through a pressurized metered-dose inhaler (pMDI) in pediatric patients with asthma has not been determined.
  
  
  OBJECTIVE
  To examine the efficacy and safety of 160 μg twice daily of budesonide through a pMDI vs placebo in children 6 to younger than 12 years with asthma and a demonstrated need for inhaled corticosteroids.
  
  
  METHODS
  A 6-week, international, multicenter, double-blinded, parallel-group, phase 2 study randomized 304 pediatric patients (mean age, 9 years; 21.7% <8 years) 1:1 to 160 μg (80 μg × 2 inhalations) twice daily of budesonide through a pMDI or placebo after a 7- to 21-day run-in period. The primary efficacy end point was change from baseline in morning peak expiratory flow (PEF); safety end points included adverse events, vital signs, and discontinuations.
  
  
  RESULTS
  Budesonide treatment significantly improved morning PEF vs placebo; mean treatment effect (budesonide vs placebo) was 13.6 L/min (P < .0001). Budesonide also showed significant improvements vs placebo for forced expiratory volume in 1 second, evening PEF, forced expiratory flow at 25% to 75% of pulmonary volume, reliever medication use, nighttime awakenings, awakenings with reliever use, and percentage of patients with at least 15- and at least 30-L/min increase in morning PEF from baseline. The numbers of patients experiencing adverse events and discontinuations were smaller in the budesonide than in the placebo group. No serious adverse events were reported.
  
  
  CONCLUSIONS
  Budesonide at 160 μg twice daily through a pMDI was generally well tolerated and significantly improved lung function, symptoms, rescue medication use, and nighttime awakenings vs placebo in children 6 to younger than 12 years with asthma and a demonstrated need for inhaled corticosteroids.
authors.affiliation: Allergy and Asthma Medical Group and Research Center, San Diego, California. Electronic address: eliomeltzer@gmail.com.
authors.forename: Eli O
authors.initials: EO
authors.lastname: Meltzer
authors.affiliation: Colorado Allergy & Asthma Centers, Denver, Colorado.
authors.forename: David S
authors.initials: DS
authors.lastname: Pearlman
authors.affiliation: AstraZeneca, Mölndal, Sweden.
authors.forename: Gӧran
authors.initials: G
authors.lastname: Eckerwall
authors.affiliation: T-STAT, LLC Statistical Consulting and Contracting, Downingtown, Pennsylvania.
authors.forename: Tom
authors.initials: T
authors.lastname: Uryniak
authors.affiliation: AstraZeneca LP, Wilmington, Delaware.
authors.forename: Michael
authors.initials: M
authors.lastname: DePietro
authors.affiliation: T-STAT, LLC Statistical Consulting and Contracting, Downingtown, Pennsylvania.
authors.forename: Kathy
authors.initials: K
authors.lastname: Lampl
mesh_terms: D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents; D019819:Budesonide