title: Efficacy and safety of the single-capsule combination of fluticasone/formoterol in patients with persistent asthma: a non-inferiority trial.
abstract: OBJECTIVE
  Fluticasone and formoterol are effective in the treatment of asthma. When a corticosteroid alone fails to control asthma, combination therapy is the treatment of choice. The objective of this study was to compare the efficacy and safety of formulations containing budesonide/formoterol (BUD/FOR), fluticasone alone (FLU), and the single-capsule combination of fluticasone/formoterol (FLU/FOR) on lung function in patients with mild-to-moderate persistent asthma.
  
  
  METHODS
  This was a randomized, multicenter, open phase III trial conducted in Brazil. The primary efficacy analysis was the assessment of non-inferiority between FLU/FOR and BUD/FOR combinations regarding FEV1 (in L) at the final visit. The secondary analyses were PEF, level of asthma control, serum cortisol levels, frequency of adverse events, adherence to treatment, and appropriate inhaler use.
  
  
  RESULTS
  We randomized 243 patients to three groups: FLU/FOR (n = 79), BUD/FOR (n = 83), and FLU (n = 81). In terms of the mean FEV1 after 12 weeks of treatment, the difference between the FLU/FOR and BUD/FOR groups was 0.22 L (95% CI: -0.06 to 0.49), whereas the difference between the FLU/FOR and FLU groups was 0.26 L (95% CI: -0.002 to 0.52). Non-inferiority was demonstrated by the difference between the lower limits of the two 95% CIs (-0.06 vs. -0.002). The level of asthma control and PEF were significantly greater in the FLU/FOR and BUD/FOR groups than in the FLU group. There were no significant differences among the groups regarding patient adherence, patient inhaler use, or safety profile of the formulations.
  
  
  CONCLUSIONS
  The single-capsule combination of FLU/FOR showed non-inferiority to the BUD/FOR and FLU formulations regarding efficacy and safety, making it a new treatment option for persistent asthma.
authors.affiliation: Medical Consulting Center for Clinical Research, Sorocaba, Brazil. Consultoria Médica em Pesquisa Clínica - CMPC, Medical Consulting Center for Clinical Research - Sorocaba, Brazil.
authors.forename: Marti
authors.initials: M
authors.lastname: Antilla
authors.affiliation: Medical Consulting Center for Clinical Research, University of São Paulo, São Paulo, Brazil, University of São Paulo School of Medicine, São Paulo, Brazil.
authors.forename: Fábio
authors.initials: F
authors.lastname: Castro
authors.affiliation: Federal University of Bahia, Salvador, Brazil. Federal University of Bahia, Salvador, Brazil.
authors.forename: Álvaro
authors.initials: Á
authors.lastname: Cruz
authors.affiliation: Federal University of Health Sciences of Porto Alegre, Porto Alegre, Brazil. Federal University of Health Sciences of Porto Alegre, Porto Alegre, Brazil.
authors.forename: Adalberto
authors.initials: A
authors.lastname: Rubin
authors.affiliation: Federal University of Paraná, Curitiba, Brazil. Federal University of Paraná, Curitiba, Brazil.
authors.forename: Nelson
authors.initials: N
authors.lastname: Rosário
authors.affiliation: University of São Paulo, School of Medicine, São Paulo, Brazil. University of São Paulo School of Medicine, São Paulo, Brazil.
authors.forename: Rafael
authors.initials: R
authors.lastname: Stelmach
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000730:Androstadienes / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D001938:Brazil; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D019819:Budesonide / Q000008:administration & dosage*; D002214:Capsules; D004338:Drug Combinations; D058995:Dry Powder Inhalers; D004983:Ethanolamines / Q000008:administration & dosage*; D005260:Female; D000068298:Fluticasone; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D016896:Treatment Outcome
chemical_list: D000730:Androstadienes; D001993:Bronchodilator Agents; D002214:Capsules; D004338:Drug Combinations; D004983:Ethanolamines; D019819:Budesonide; D000068298:Fluticasone; D000068759:Formoterol Fumarate
keywords: Administration, inhalation; Asthma; Bronchodilator agents; Steroids