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S9 Equivalence Of Fluticasone Propionate/Salmeterol Delivered Via AirFluSal® Forspiro® And Seretide® Accuhaler® In Adolescent And Adult Asthma
  1. P Kuna1,
  2. I Gath2,
  3. U Thyroff-Friesinger2,
  4. S Jones3
  1. 1Medical University of Lodz, Lodz, Poland
  2. 2Hexal AG, Holzkirchen, Germany
  3. 3Sandoz International GmbH, Holzkirchen, Germany

Abstract

Introduction and objectives Guideline-defined asthma control may be achieved and maintained in the majority of patients by treatment with a combination of a corticosteroid and a long-acting ß2-agonist. AirFluSal® Forspiro®, a multi-dose dry powder inhaler (mDPI), provides this proven combination of inhaled corticosteroid fluticasone propionate (FP) and a long-acting inhaled ß2-agonist salmeterol (Sal). This study compared the efficacy of AirFluSal® Forspiro® with Seretide® Accuhaler® in adolescent and adult patients with moderate-to-severe persistent asthma.

Methods This study, conducted in 279 patients (12–65 years) with GINA guideline-defined moderate-to-severe persistent asthma, was undertaken as a double-blind, double-dummy, parallel-group, multicentre trial. Patients were randomised to 12 weeks treatment with AirFluSal® Forspiro® 500 µg/50 µg, or Seretide® Accuhaler® 500 µg/50 µg. Primary efficacy measures were the change from baseline of the forced expiratory volume in 1 s (FEV1) to show non-inferiority of AirFluSal® Forspiro® to Seretide® Accuhaler® (non-inferiority margin Δ = -0.200 L) and the area under the FEV1 curve at study termination (AUC0–12). Secondary endpoints included mean changes in FEV1, FEV1% predicted, morning peak expiratory flow (PEF) and global evaluation of efficacy. Safety was assessed and patient preference for each device was rated using a visual analogue scale (VAS).

Results Assessment of the effect of treatment on the absolute change in FEV1 from baseline to study termination demonstrated non-inferiority between AirFluSal® Forspiro® and Seretide® Accuhaler® (difference in least squares mean [95% CI] = -0.032 L [-0.121;0.057]). Assessment of AUC0–12 at study termination demonstrated equivalence between devices. All secondary efficacy measures demonstrated comparable results for both inhalers, with no significant differences observed. The use of rescue medication and the average asthma symptom scores decreased from baseline in a similar manner for both devices. Overall safety profiles were equivalent. Patient ratings for each device were 81.97 ± 13.89 mm VAS for AirFluSal® Forspiro® and 79.67 ± 16.48 mm VAS for Seretide® Accuhaler® (data includes 276 patients randomised at baseline to use the devices at a dose of 100 µg/50 µg).

Abstract S9 Figure 1

Effect of treatment on baseline* FEV1 by inhalation with AirFluSal® Forpiro® 500 mg/50 mg or Seretide® 500 Accuhaler®

Conclusions AirFluSal® Forspiro® shows therapeutic equivalence to Seretide® Accuhaler®, providing a proven combination treatment in an intuitive, easy-to-use device.

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