RT Journal Article
SR Electronic
T1 Efficacy and safety of extrafine glycopyrronium bromide pMDI (CHF 5259) in COPD patients
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP PA4065
DO 10.1183/13993003.congress-2016.PA4065
VO 48
IS suppl 60
A1 Elzbieta Hajol
A1 Annalisa Piccinno
A1 Isabelle Viaud
A1 Isabella Montagna
A1 Alessandro Guasconi
A1 Stefano Vezzoli
A1 Mario Scuri
A1 Mike Polkey
YR 2016
UL http://erj.ersjournals.com/content/48/suppl_60/PA4065.abstract
AB 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.