BACKGROUND: No standard, optimal treatment exists for severe intermittent (ie, episodic) asthma in children. However, evidence suggests that both daily and episode-driven montelukast are effective for this phenotype. OBJECTIVE: To assess the regimen-related efficacy of montelukast in treating pediatric episodic asthma. METHODS: A multicenter, randomized, double-blind, double-dummy, parallel-group, 52-week study was performed in children 6 months to 5 years of age comparingplacebo with two regimens of montelukast 4 mg: (1) daily; or (2) episode-driven for 12 days beginning with signs/symptoms consistent with imminent cold or breathing problem. The main outcome measure was the number of asthma episodes (symptoms requiring treatment) culminating in an asthma attack (symptoms requiring physician visit, emergency room visit, corticosteroids, or hospitalization). RESULTS:Five hundred eighty-nine patients were randomized to daily montelukast, 591 to intermittent montelukast, and 591 to placebo. Compared with placebo, no significant difference was seen between daily montelukast (P = .510) or intermittent montelukast (P = .884) in the number of asthma episodes culminating in an asthma attack over 1 year. Daily montelukast reduced symptoms over the 12-day treatment period of asthma episodes compared with placebo (P = .045). Beta-agonist use was reduced with both daily (P = .048) and intermittent montelukast (P = .028) compared with placebo. However, because of prespecified rules for multiplicity adjustments (requiring a positive primary endpoint), statistical significance for secondary endpoints cannot be concluded. All treatments were well tolerated. CONCLUSIONS:Montelukast did not reduce the number of asthma episodes culminating in an asthma attack over 1 year in children 6 months to 5 years of age, although numerical improvements occurred in some endpoints.
RCT Entities:
BACKGROUND: No standard, optimal treatment exists for severe intermittent (ie, episodic) asthma in children. However, evidence suggests that both daily and episode-driven montelukast are effective for this phenotype. OBJECTIVE: To assess the regimen-related efficacy of montelukast in treating pediatric episodic asthma. METHODS: A multicenter, randomized, double-blind, double-dummy, parallel-group, 52-week study was performed in children 6 months to 5 years of age comparing placebo with two regimens of montelukast 4 mg: (1) daily; or (2) episode-driven for 12 days beginning with signs/symptoms consistent with imminent cold or breathing problem. The main outcome measure was the number of asthma episodes (symptoms requiring treatment) culminating in an asthma attack (symptoms requiring physician visit, emergency room visit, corticosteroids, or hospitalization). RESULTS: Five hundred eighty-nine patients were randomized to daily montelukast, 591 to intermittent montelukast, and 591 to placebo. Compared with placebo, no significant difference was seen between daily montelukast (P = .510) or intermittent montelukast (P = .884) in the number of asthma episodes culminating in an asthma attack over 1 year. Daily montelukast reduced symptoms over the 12-day treatment period of asthma episodes compared with placebo (P = .045). Beta-agonist use was reduced with both daily (P = .048) and intermittent montelukast (P = .028) compared with placebo. However, because of prespecified rules for multiplicity adjustments (requiring a positive primary endpoint), statistical significance for secondary endpoints cannot be concluded. All treatments were well tolerated. CONCLUSIONS:Montelukast did not reduce the number of asthma episodes culminating in an asthma attack over 1 year in children 6 months to 5 years of age, although numerical improvements occurred in some endpoints.
Authors: Malcolm Brodlie; Atul Gupta; Carlos E Rodriguez-Martinez; Jose A Castro-Rodriguez; Francine M Ducharme; Michael C McKean Journal: Cochrane Database Syst Rev Date: 2015-10-19
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
Authors: Chinedu Nwokoro; Hitesh Pandya; Stephen Turner; Sandra Eldridge; Christopher J Griffiths; Tom Vulliamy; David Price; Marek Sanak; John W Holloway; Rossa Brugha; Lee Koh; Iain Dickson; Clare Rutterford; Jonathan Grigg Journal: Lancet Respir Med Date: 2014-09-08 Impact factor: 30.700
Authors: Hasan R Hussein; Atul Gupta; Simon Broughton; Gary Ruiz; Nicola Brathwaite; Cara J Bossley Journal: Eur J Pediatr Date: 2017-06-01 Impact factor: 3.183