title: Randomized equivalence trial: A novel multidose dry powder inhaler and originator device in adult and adolescent asthma.
abstract: BACKGROUND
  Guideline-defined asthma control can be achieved and maintained in patients by treatment with fluticasone propionate-salmeterol (FP-Sal).
  
  
  OBJECTIVE
  To compare the efficacy and safety of FP-Sal delivered via a novel multidose dry powder inhaler (mDPI) versus an originator device in adolescent and adult patients with moderate-to-severe persistent asthma.
  
  
  METHODS
  Patients ages 12-65 years (N = 555) were randomized to treatment with FP-Sal novel mDPI 100 μg-50 μg or 500 μg-50 μg, or originator device 100 μg-50 μg or 500 μg-50 μg in a double-blind, double-dummy, parallel-group, multicenter study. Primary efficacy measures were absolute change in forced expiratory volume in 1 second (FEV1) from baseline and the area under the 12-hour serial FEV1 curve at the end of 12 weeks of treatment. Secondary end points included mean changes in FEV1; FEV1 % predicted; morning predose peak expiratory flow; daytime, nighttime, total asthma symptom scores; rescue medication use; percentage of patients with guideline-defined controlled asthma; global efficacy evaluation; patients' device preference; and safety.
  
  
  RESULTS
  FP-Sal mDPI and originator device-mediated increases in FEV1 from baseline to the end of treatment were not significantly different, difference in least squares mean, -0.065 L (95% confidence interval, -0.154 to 0.024 L) at 100 μg-50 μg, and -0.032 L (95% confidence interval, -0.121 to 0.057 L) at 500 μg-50 μg). Both doses of FP-Sal mDPI improved FEV1 area under the 12-hour serial FEV1 curve from baseline and all secondary efficacy measures with no significant differences from the originator device at equivalent doses, with similar safety profiles.
  
  
  CONCLUSIONS
  FP-Sal mDPI demonstrated equivalent efficacy and safety profile to the originator device and is an alternative in this patient group.
authors.affiliation: Division of Internal Medicine, Barlicki University Hospital, Medical University of Lódz, Lódz, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Kuna
authors.forename: Ursula
authors.initials: U
authors.lastname: Thyroff-Friesinger
authors.forename: Ingolf
authors.initials: I
authors.lastname: Gath
authors.forename: Spencer
authors.initials: S
authors.lastname: Jones
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D058995:Dry Powder Inhalers / Q000706:statistics & numerical data*; D000068297:Fluticasone-Salmeterol Drug Combination / Q000008:administration & dosage* / Q000009:adverse effects; D005541:Forced Expiratory Volume; D006801:Humans; D008875:Middle Aged; D057240:Patient Preference; D017410:Practice Guidelines as Topic; D055815:Young Adult
chemical_list: D000068297:Fluticasone-Salmeterol Drug Combination