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P127 Superiority of glycopyrronium versus tiotropium in early onset of bronchodilation in patients with moderate to severe COPD – the FAST study
  1. H Watz1,
  2. C Mailaender2,
  3. A-M Kirsten1
  1. 1Pulmonary Research Institute at Lung Clinic Grosshansdorf, Grosshansdorf, Germany
  2. 2Novartis Pharma GmbH, Nuremberg, Germany

Abstract

Background Glycopyrronium (GLY) has demonstrated efficacy similar to open-label and single-blinded tiotropium (TIO) in the treatment of COPD and fast onset of bronchodilation action.1,2 The double-blinded FAST study compared the efficacy of GLY with TIO in serial spirometry and bodyplethysmography measurements to allow for a more intensified characterisation of the earlier onset of action.

Methods In this multicenter, randomised, double-blinded, double-dummy, cross-over study patients (pts) with moderate-to-severe COPD received single-dose of both once- daily GLY 44 μg and TIO 18 μg via the Breezhaler® and Handihaler® devices respectively. Primary endpoint was the forced expiratory volume in one second (FEV1) AUC –2h. Other endpoints included inspiratory capacity (IC), residual volume (RV), functional residual capacity (FRC) and specific airway resistance (sRaw), all measured by bodyplethysmography.

Results Of 152 pts randomised (mean age: 61.8 yr, mean post-bronchodilator FEV1: 52.1%) 99.3% completed the study. After inhalation of the single dose, GLY demonstrated superiority to TIO in early bronchodilation i.e. FEV1 AUC –2h (least squares mean (LSM) = 0.037 L, p = 0.0006). Both treatments showed similar improvements in IC, RV, and FRCpleth. Over the first 90 min after dosing, GLY also showed statistically significant improvement in sRaw compared to TIO with a difference of 0,184 kPa*s at the time point 90 min (LSM, p = 0.006).

Conclusion GLY showed effective bronchodilation and was superior to double-blinded TIO in terms of early onset of bronchodilation. Both GLY and TIO showed similar improvements in static lung volume parameters; however GLY was superior in reduction of sRaw early after inhalation.

References 1 Kerwin E, et al. Eur Resp J 2012;40:1106–1114

2 Chapman, et al. BMC Pulm Med. 2014;14:4

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