title: A randomized, double-blinded, double-dummy efficacy and safety study of budesonide-formoterol Spiromax® compared to budesonide-formoterol Turbuhaler® in adults and adolescents with persistent asthma.
abstract: BACKGROUND
  Budesonide and formoterol (BF) Spiromax® is a dry powder inhaler designed to deliver BF with maximum ease of use for patients with asthma or chronic obstructive pulmonary disease.
  
  
  METHODS
  A phase 3b, 12-week, multicenter, double-blind, double-dummy, randomized, controlled trial in patients (≥12 years) with persistent asthma.
  
  
  OBJECTIVE
  to demonstrate non-inferiority of twice-daily BF Spiromax 160/4.5 mcg to BF Turbuhaler® 200/6 mcg in change from baseline in weekly average of daily trough morning peak expiratory flow (PEF). Secondary endpoints included: Patient Satisfaction and Preference Questionnaire scores, change from baseline in evening PEF, trough forced expiratory volume in one second, percentage of symptom-free and rescue-free 24-hour periods, and safety.
  
  
  RESULTS
  The analysis was based on the per-protocol population (BF Spiromax, n = 290; BF Turbuhaler, n = 284). The least squares mean change from baseline to week 12 in morning PEF was: BF Spiromax, 18.8 L/min and BF Turbuhaler, 21.8 L/min. Non-inferiority of BF Spiromax vs BF Turbuhaler was demonstrated (the lower limit of the 95% two-sided confidence interval was -9.02 L/min, which is greater than -15 L/min [the criteria specified for non-inferiority]). The mean difference in the total performance domains scores for BF Spiromax vs BF Turbuhaler were 0.248 at baseline and 0.353 at week 12 (both, p <0.001), indicating statistical superiority for BF Spiromax. No statistical or numerical differences were recorded in the total convenience domain score between the two devices. Scores for 'device preference' and 'willingness to continue' supported BF Spiromax at baseline and at week 12 (p = 0.0005 vs BF Turbuhaler). No significant between-group differences were observed in the other secondary efficacy endpoints. Both treatments were well tolerated, with no significant differences in adverse events or asthma exacerbations.
  
  
  CONCLUSIONS
  This study demonstrates the non-inferiority of BF Spiromax vs BF Turbuhaler in patients (≥12 years) with asthma. More patients preferred the Spiromax device over Turbuhaler for its performance, and were willing to continue therapy with BF Spiromax beyond the 12-week study period.
  
  
  BACKGROUND
  NCT01803555; February 28, 2013.
authors.affiliation: Department of Pneumology/Intensive Care Medicine, University of Rostock, Zentrum für Innere Medizin/Medizinische Klinik 1, Rostock, Germany. j.c.virchow@med.uni-rostock.ch.
authors.forename: J Christian
authors.initials: JC
authors.lastname: Virchow
authors.affiliation: Servei de Pneumologia (Institut del Tòrax), Hospital Clínic-IDIBAPS-CIBERES, Universitat de Barcelona, Barcelona, Spain.
authors.forename: Roberto
authors.initials: R
authors.lastname: Rodriguez-Roisin
authors.affiliation: University of Ferrara, Ferrara, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Papi
authors.affiliation: Teva Pharmaceuticals, Malvern, PA, USA.
authors.forename: Tushar P
authors.initials: TP
authors.lastname: Shah
authors.affiliation: Teva Pharmaceuticals, Malvern, PA, USA.|, Present address: 41 Spruce Hollow Road, Green Brook, NJ, 08812, USA.
authors.forename: Gokul
authors.initials: G
authors.lastname: Gopalan
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D019819:Budesonide / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D058995:Dry Powder Inhalers; D005260:Female; D005541:Forced Expiratory Volume; D000068759:Formoterol Fumarate / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D057240:Patient Preference; D017060:Patient Satisfaction; D010366:Peak Expiratory Flow Rate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D001993:Bronchodilator Agents; D004338:Drug Combinations; D019819:Budesonide; D000068759:Formoterol Fumarate
keywords: Asthma; Budesonide; Formoterol; Patient satisfaction and preference questionnaire for inhalation devices; Pulmonary; Safety; Spiromax; Turbuhaler