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P233 Efficacy and safety of once-daily glycopyrronium compared with blinded tiotropium in patients with COPD: the GLOW5 study
  1. KR Chapman1,
  2. K Beeh2,
  3. ED Bateman3,
  4. J Beier2,
  5. AD D'Urzo4,
  6. R Nutbrown5,
  7. H Chen6,
  8. M Henley6,
  9. T Overend5,
  10. P D'Andrea6
  1. 1Toronto Western Hospital, Toronto, Canada
  2. 2Respiratory Research Institute, Wiesbaden, Germany
  3. 3University of Cape Town, Cape Town, South Africa
  4. 4University of Toronto, Ontario, Canada
  5. 5Novartis Horsham Research Centre, Horsham, UK
  6. 6Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

Abstract

Background Glycopyrronium, a once-daily long-acting muscarinic antagonist (LAMA), has demonstrated a similar efficacy and safety profile to open-label tiotropium in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).1 The GLOW5 study compared the efficacy and safety of glycopyrronium with blinded tiotropium.

Methods In this multicentre, 12-week, blinded study, patients ≥ 40 years with moderate-to-severe COPD (post-bronchodilator FEV1 ≥ 30% and < 80% of the predicted normal, post-bronchodilator FEV1/FVC < 0.70) and a smoking history of ≥10 pack-years were randomised to glycopyrronium 50μg (via Breezhaler® device) or tiotropium 18μg (via HandiHaler® device). The primary objective was to demonstrate non-inferiority of glycopyrronium versus tiotropium for trough FEV1 at Week 12 (non-inferiority margin: –50 mL). Other endpoints included FEV1 area under the curve from 0 to 4 hours (AUC0–4hr) on Day 1, Transition Dyspnoea Index (TDI), St George's Respiratory Questionnaire (SGRQ), rescue medication use, exacerbation rate, safety and tolerability.

Results Of the 657 patients randomised, (glycopyrronium [n = 327]; tiotropium [n = 330]; mean age: 63.5 years, mean post-bronchodilator FEV1: 53.5% predicted), 95.9% completed the study. Glycopyrronium demonstrated non-inferiority to tiotropium for trough FEV1 at Week 12 (Least Squares Mean [LSM] = 1.41L for both the groups; 95% confidence interval [CI]: –0.032, 0.031L). Glycopyrronium had a rapid onset of bronchodilation in the morning as demonstrated by a higher FEV1 AUC0–4hr on Day 1 compared to tiotropium (LSM treatment difference [Td] = 58mL; p < 0.001). At Week 12, TDI total score (Td = –0.188; p = 0.385), SGRQ total score (Td = 0.65; p = 0.488) and percentage of days with no rescue medication use (Td = –1.5; p = 0.528) were comparable between the groups. No significant treatment difference was observed with respect to rate of moderate/severe COPD exacerbations per year (glycopyrronium 0.38 versus tiotropium 0.35 [rate ratio = 1.10, 95% CI: 0.62, 1.93]; p = 0.754). Overall, the incidence of adverse events was similar in the glycopyrronium (40.4%) and tiotropium (40.6%) groups.

Conclusion Glycopyrronium and blinded tiotropium showed similar improvements in lung function, dyspnoea, health status, exacerbation rate and rescue medication use, with a similar safety and tolerability profile. Onset of bronchodilation with glycopyrronium was significantly more rapid following the first dose.

Reference

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

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