BACKGROUND:Mometasone furoate nasal spray (MFNS) improves nasal symptoms and reduces polyp size in adults with nasal polyposis. This 4-month, multinational, randomized, double-blind study was conducted to assess the safety of MFNS in pediatric subjects aged 6-17 yr. METHODS:Subjects aged 6-11 yr with bilateral nasal polyps received MFNS 100 μg once or twice daily or placebo; those aged 12-17 yr received MFNS 200 μg once or twice daily or placebo. End-points included change in 24-h urinary free cortisol (primary), change in 24-h urinary free cortisol corrected for creatinine (key secondary), and adverse events. Efficacy parameters included polyp size, nasal symptoms, and investigator-evaluated therapeutic response, although the study was not powered for statistical analysis of efficacy. RESULTS: Least squares baseline mean urinary free cortisol level (nmol/24 h) for both age groups combined (N = 127) was 49.5 in the MFNS once-daily group, 39.6 in the MFNS twice-daily group, and 49.8 in the placebo group. Change in 24-h urinary free cortisol did not significantly differ among MFNS- and placebo-treated subjects. Least squares mean 24-h urinary free cortisol levels corrected for creatinine also showed no significant differences among MFNS- and placebo-treated subjects. No safety issues emerged. CONCLUSIONS: Results of this study confirm the safety profile of MFNS in pediatric patients with bilateral nasal polyps over 4 months, even at double the recommended pediatric dosage for allergic rhinitis.
RCT Entities:
BACKGROUND:Mometasone furoate nasal spray (MFNS) improves nasal symptoms and reduces polyp size in adults with nasal polyposis. This 4-month, multinational, randomized, double-blind study was conducted to assess the safety of MFNS in pediatric subjects aged 6-17 yr. METHODS: Subjects aged 6-11 yr with bilateral nasal polyps received MFNS 100 μg once or twice daily or placebo; those aged 12-17 yr received MFNS 200 μg once or twice daily or placebo. End-points included change in 24-h urinary free cortisol (primary), change in 24-h urinary free cortisol corrected for creatinine (key secondary), and adverse events. Efficacy parameters included polyp size, nasal symptoms, and investigator-evaluated therapeutic response, although the study was not powered for statistical analysis of efficacy. RESULTS: Least squares baseline mean urinary free cortisol level (nmol/24 h) for both age groups combined (N = 127) was 49.5 in the MFNS once-daily group, 39.6 in the MFNS twice-daily group, and 49.8 in the placebo group. Change in 24-h urinary free cortisol did not significantly differ among MFNS- and placebo-treated subjects. Least squares mean 24-h urinary free cortisol levels corrected for creatinine also showed no significant differences among MFNS- and placebo-treated subjects. No safety issues emerged. CONCLUSIONS: Results of this study confirm the safety profile of MFNS in pediatric patients with bilateral nasal polyps over 4 months, even at double the recommended pediatric dosage for allergic rhinitis.
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: Lee Yee Chong; Karen Head; Claire Hopkins; Carl Philpott; Martin J Burton; Anne G M Schilder Journal: Cochrane Database Syst Rev Date: 2016-04-26
Authors: Lee Yee Chong; Karen Head; Claire Hopkins; Carl Philpott; Anne G M Schilder; Martin J Burton Journal: Cochrane Database Syst Rev Date: 2016-04-26