title: A 12-week open-label, randomized, controlled trial and 24-week extension to assess the efficacy and safety of fluticasone propionate/formoterol in children with asthma.
abstract: The present study was conducted to assess the efficacy, safety and tolerability of fluticasone propionate/formoterol fumarate combination therapy (FP/FORM; Flutiform®) compared with fluticasone propionate/salmeterol xinafoate (FP/SAL; Seretide® Evohaler®) in children with asthma.
  
  
  
  This was an open-label, randomized, controlled, phase III trial and extension. Patients aged 4-12 years with reversible asthma [% predicted forced expiratory volume in 1 second (FEV1) 60-100%; documented reversibility of ⩾15% in FEV1] were randomized to receive FP/FORM (100/10 µg b.i.d.) or FP/SAL (100/50 µg b.i.d.) for 12 weeks. Eligible patients completing the 12-week core phase entered a 24-week extension phase with FP/FORM (100/10 µg b.i.d.). The primary efficacy endpoint was the change in predose FEV1 from day 0 to day 84. Secondary efficacy endpoints included change in predose to 2-hours postdose FEV1 from day 0 to day 84, peak expiratory flow rate (PEFR), patient-reported outcomes, rescue-medication use and asthma exacerbations.
  
  
  
  In total, 211 patients were randomized and 210 completed the core phase; of these patients, 208 entered and 205 completed the extension phase of the study. Predose FEV1 increased from day 0 to day 84 [FP/FORM, 182 ml; 95% confidence interval (CI), 127, 236; FP/SAL, 212 ml, 95% CI, 160, 265] and FP/FORM was noninferior to FP/SAL: least squares (LS) mean treatment difference: -0.031 (95% CI, -0.093, 0.031; p = 0.026). Secondary efficacy analyses indicated similar efficacy with both therapies. There were no notable differences observed in the safety and tolerability profile between treatments. No safety concerns were identified with long-term FP/FORM therapy, and there was no evidence of an effect of FP/FORM on plasma cortisol.
  
  
  
  FP/FORM improved lung function and measures of asthma control with comparable efficacy to FP/SAL, and demonstrated a favourable safety and tolerability profile in children aged 4-12 years.
authors.affiliation: Department of Paediatric Lung Diseases and Rheumatology, Medical University, Lublin, Poland andrzejemeryk@plusnet.pl.
authors.forename: Andrzej
authors.initials: A
authors.lastname: Emeryk
authors.affiliation: Cabinet de Pédiatrie et de Pneumo Allergologie Pédiatriques, Laon, France.
authors.forename: Rabih
authors.initials: R
authors.lastname: Klink
authors.affiliation: Mundipharma Research Limited, Cambridge, UK.
authors.forename: Tammy
authors.initials: T
authors.lastname: McIver
authors.affiliation: Mundipharma Research Limited, Cambridge, UK.
authors.forename: Prashant
authors.initials: P
authors.lastname: Dalvi
mesh_terms: D000730:Androstadienes / Q000009:adverse effects / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004338:Drug Combinations; D004983:Ethanolamines / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D000068298:Fluticasone; D000068297:Fluticasone-Salmeterol Drug Combination / Q000009:adverse effects / Q000627:therapeutic use*; D005541:Forced Expiratory Volume; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D010366:Peak Expiratory Flow Rate; D012129:Respiratory Function Tests; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D004338:Drug Combinations; D004983:Ethanolamines; D000068297:Fluticasone-Salmeterol Drug Combination; C586520:fluticasone-formoterol; D000068298:Fluticasone; D000068759:Formoterol Fumarate
keywords: asthma; children; combination therapy; fluticasone propionate; formoterol fumarate; pMDI