Abstract
Introduction: CHF 5259 pMDI is an extrafine formulation of Glycopyrronium Bromide (GB; 12.5 µg/actuation) to be combined with a fixed dose combination of Beclometasone Dipropionate and Formoterol Fumarate (Foster® 100/6 µg/actuation)as a two inhalations b.i.d. treatment in asthma and COPD.
Main Objectives: To demonstrate the superiority of CHF 5259 pMDI vs. placebo in pre-dose morning FEV1and to assess safety and tolerability.
Methods: Double-blind, randomised, 2-way crossover, placebo-controlled study. One hundred moderate/very severe COPD patients were randomised to receive either GB 12.5 µg 2 puffs b.i.d. or placebo over 4 weeks, with a 1-week wash-out period. The primary efficacy variable was change from baseline in pre-dose morning FEV1 on Day 28. The key secondary efficacy variable was FEV1 AUC0-12h on Day 28. TDI and SGRQ score at Day 28 were included as secondary variables.
Results: Pre-dose morning FEV1 on Day 28 was higher in the treated group compared to placebo, with an adjusted mean difference (95% CI) between treatments of 0.088 L (0.039; 0.137) (p<0.001). Treatment with CHF 5259 pMDI also resulted in significant improvements in FEV1 AUC0-12h on Day 28, with an adjusted mean difference of 0.121 L (0.079; 0.162) (p<0.001). TDI focal score and SGRQ total score on Day 28 significantly improved with CHF 5259 pMDI (adjusted mean difference vs placebo [95% CI] 0.84 [0.21; 1.47]; p= 0.010 and -2.15 [-4.08; -0.23]; p= 0.029 respectively). Safety profile was comparable to placebo.
Conclusion: CHF 5259 pMDI provides superior clinical benefits compared to placebo in COPD patients with moderate/very severe lung function impairment over 4 weeks of treatment with a good safety profile.
- Copyright ©the authors 2016