Abdullah A Alangari1, Nidal Malhis2, Mohamed Mubasher3, Najwa Al-Ghamedi4, Mohamad Al-Tannir3, Muhammad Riaz3, Dale T Umetsu5, Saleh Al-Tamimi2. 1. Department of Pediatrics, College of Medicine, King Saud University, Riyadh, Saudi Arabia. Electronic address: aangari@ksu.edu.sa. 2. Department of Emergency Medicine, King Fahad Medical City, Riyadh, Saudi Arabia. 3. Research and Scientific Publication Centre, King Fahad Medical City, Riyadh, Saudi Arabia. 4. Pharmacy Services Administration, King Fahad Medical City, Riyadh, Saudi Arabia. 5. Boston Children's Hospital, Harvard Medical School, Boston, MA.
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. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01524198; URL: www.clinicaltrials.gov
RCT Entities:
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. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01524198; URL: www.clinicaltrials.gov
Authors: Abdullah A Alangari; Muhammad Riaz; Mohamed Osman Mahjoub; Nidal Malhis; Saleh Al-Tamimi; Abdullah Al-Modaihsh Journal: Ann Thorac Med Date: 2015 Jan-Mar Impact factor: 2.219
Authors: Marzia Duse; Francesca Santamaria; Maria Carmen Verga; Marcello Bergamini; Giovanni Simeone; Lucia Leonardi; Giovanna Tezza; Annamaria Bianchi; Annalisa Capuano; Fabio Cardinale; Giovanni Cerimoniale; Massimo Landi; Monica Malventano; Mariangela Tosca; Attilio Varricchio; Anna Maria Zicari; Carlo Alfaro; Salvatore Barberi; Paolo Becherucci; Roberto Bernardini; Paolo Biasci; Carlo Caffarelli; Valeria Caldarelli; Carlo Capristo; Serenella Castronuovo; Elena Chiappini; Renato Cutrera; Giovanna De Castro; Luca De Franciscis; Fabio Decimo; Iride Dello Iacono; Lucia Diaferio; Maria Elisa Di Cicco; Caterina Di Mauro; Cristina Di Mauro; Dora Di Mauro; Francesco Di Mauro; Gabriella Di Mauro; Mattia Doria; Raffaele Falsaperla; Valentina Ferraro; Vassilios Fanos; Elena Galli; Daniele Giovanni Ghiglioni; Luciana Indinnimeo; Ahmad Kantar; Adima Lamborghini; Amelia Licari; Riccardo Lubrano; Stefano Luciani; Francesco Macrì; Gianluigi Marseglia; Alberto Giuseppe Martelli; Luigi Masini; Fabio Midulla; Domenico Minasi; Vito Leonardo Miniello; Michele Miraglia Del Giudice; Sergio Renzo Morandini; Germana Nardini; Agostino Nocerino; Elio Novembre; Giovanni Battista Pajno; Francesco Paravati; Giorgio Piacentini; Cristina Piersantelli; Gabriella Pozzobon; Giampaolo Ricci; Valter Spanevello; Renato Turra; Stefania Zanconato; Melissa Borrelli; Alberto Villani; Giovanni Corsello; Giuseppe Di Mauro; Diego Peroni Journal: Ital J Pediatr Date: 2021-04-21 Impact factor: 2.638