title: Budesonide nebulization added to systemic prednisolone in the treatment of acute asthma in children: a double-blind, randomized, controlled trial.
abstract: BACKGROUND
  Inhaled corticosteroids, known to be effective as a maintenance medication in chronic asthma, have also been suggested as a therapy for acute asthma when given at high doses.
  
  
  METHODS
  A double-blind, randomized, placebo-controlled trial was conducted in children aged 2 to 12 years with moderate or severe acute asthma, as determined based on a clinical score of 5 to 15 points, where 15 is the most severe. We compared the addition of budesonide 1,500 μg vs placebo to standard acute asthma treatment, which included salbutamol, ipratropium bromide, and a single dose of prednisolone 2 mg/kg given at the beginning of therapy. The primary outcome was hospital admission rate within 4 h.
  
  
  RESULTS
  A total of 906 ED visits by children with moderate or severe acute asthma were evaluated. Seventy-five cases out of 458 (16.4%) in the budesonide group vs 82 of 448 (18.3%) in the placebo group were admitted (OR, 0.84; 95% CI, 0.58-1.23; P=.38). However, among cases with high baseline clinical score (≥13), significantly fewer children were admitted in the budesonide group (27 of 76 [35.5%]) than in the placebo group (39 of 73 [53.4%]; OR, 0.42; 95% CI, 0.19-0.94; P=.03).
  
  
  CONCLUSIONS
  The addition of budesonide nebulization did not decrease the admission rate of children with acute asthma overall. However, it may decrease the admission rate of children with severe acute asthma.
  
  
  BACKGROUND
  ClinicalTrials.gov; No.: NCT01524198; URL: www.clinicaltrials.gov
authors.affiliation: Department of Pediatrics, College of Medicine, King Saud University, Riyadh, Saudi Arabia. Electronic address: aangari@ksu.edu.sa.
authors.forename: Abdullah A
authors.initials: AA
authors.lastname: Alangari
authors.affiliation: Department of Emergency Medicine, King Fahad Medical City, Riyadh, Saudi Arabia.
authors.forename: Nidal
authors.initials: N
authors.lastname: Malhis
authors.affiliation: Research and Scientific Publication Centre, King Fahad Medical City, Riyadh, Saudi Arabia.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Mubasher
authors.affiliation: Pharmacy Services Administration, King Fahad Medical City, Riyadh, Saudi Arabia.
authors.forename: Najwa
authors.initials: N
authors.lastname: Al-Ghamedi
authors.affiliation: Research and Scientific Publication Centre, King Fahad Medical City, Riyadh, Saudi Arabia.
authors.forename: Mohamad
authors.initials: M
authors.lastname: Al-Tannir
authors.affiliation: Research and Scientific Publication Centre, King Fahad Medical City, Riyadh, Saudi Arabia.
authors.forename: Muhammad
authors.initials: M
authors.lastname: Riaz
authors.affiliation: Boston Children's Hospital, Harvard Medical School, Boston, MA.
authors.forename: Dale T
authors.initials: DT
authors.lastname: Umetsu
authors.affiliation: Department of Emergency Medicine, King Fahad Medical City, Riyadh, Saudi Arabia.
authors.forename: Saleh
authors.initials: S
authors.lastname: Al-Tamimi
mesh_terms: D000208:Acute Disease; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D019819:Budesonide / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D009330:Nebulizers and Vaporizers; D011239:Prednisolone / Q000008:administration & dosage*
chemical_list: D001993:Bronchodilator Agents; D005938:Glucocorticoids; D019819:Budesonide; D011239:Prednisolone