Article Text

PDF

COPD and drugs: new and old concepts
P253 NVA237 once daily offers rapid and clinically meaningful bronchodilation in COPD patients that is maintained for 24 h: the GLOW1 trial
  1. T D'Urzo1,
  2. G Ferguson2,
  3. C Martin3,
  4. V K T Alagappan3,
  5. D Banerji4,
  6. Y Lu4,
  7. R Horton3,
  8. T Overend3
  1. 1Department of Family and Community Medicine, University of Toronto, Ontario, Canada
  2. 2Pulmonary Research Institute of Southeast Michigan, Livonia, Michigan, USA
  3. 3Novartis Horsham Research Centre, Horsham, West Sussex, UK
  4. 4Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA

Abstract

Introduction NVA237 (glycopyrronium bromide) is an inhaled long-acting muscarinic antagonist (LAMA) in development for the once-daily (qd) treatment of COPD. The GLOW1 study evaluated the efficacy and safety of NVA237 in patients with moderate-to-severe COPD.

Methods Patients were randomised (2:1) to 26 weeks double-blind treatment with NVA237 50 μg qd or placebo (PBO). Study drugs were administered via a single-dose dry powder inhaler (Breezhaler® device). Primary efficacy endpoint: trough FEV1 (mean of 23 h 15 min and 23 h 45 min post-dose values) vs PBO after 12 weeks.

Results 822 patients were randomised; mean age was 63.9 years, mean post-bronchodilator FEV1 was 55% predicted. 80.5% completed the study. At Week 12 there was a statistically significant and clinically relevant difference between NVA237 vs PBO in mean trough FEV1 (108 ml; p<0.001). Trough FEV1 was also significantly higher at Day 1 and Week 26 (treatment difference: 105 ml and 113 ml, respectively; p<0.001). Serial spirometry in a subpopulation of patients showed statistically superior (p<0.001) and clinically meaningful improvements in FEV1 with NVA237 vs PBO at all timepoints on Day 1, Week 12 and Week 26. NVA237 had a rapid onset of action with an increased FEV1 of 93 ml at 5 min and 144 ml at 15 min vs PBO after the first dose on Day 1 (p<0.001). Overall, the incidence of adverse events (AEs) was similar between treatment groups (NVA237: 57.5%; PBO: 65.2%). Serious AEs were reported by 7.5% of NVA237- vs 9.0% of PBO-treated patients.

Conclusion NVA237 50 μg once daily was generally safe and well tolerated. Improvements in bronchodilation were rapid, clinically meaningful and maintained for 24 h throughout the study.

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.