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Randomised clinical trials in COPD
S50 Once-daily glycopyrronium improves lung function in COPD patients: pooled results of the GLOW1 and GLOW2 studies
  1. D Banerji1,
  2. V Alagappan1,
  3. C Martin2,
  4. E He1,
  5. H Chen1,
  6. T Overend2
  1. 1Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
  2. 2Novartis Horsham Research Centre, Horsham, West Sussex, UK

Abstract

Introduction NVA237 (glycopyrronium) is a safe and effective once-daily inhaled long-acting muscarinic antagonist for the maintenance treatment of COPD.

Methods This pooled analysis of the Glycopyrronium Bromide in COPD Airways Clinical Studies (GLOW1 and 2) assessed the efficacy of glycopyrronium 50µg once daily versus placebo and open-label tiotropium 18µg once daily over 26 to 52 weeks in patients with moderate-to-severe COPD. Glycopyrronium and placebo were delivered via the Breezhaler® device and tiotropium was delivered via the Handihaler® device, in the morning between 8:00–11:00 hours. Analyses included trough forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) at Day 1 and Weeks 12, 26 and 52; 24hour (h) serial spirometry in a subset of patients, and FEV1 area under the curve (AUC).

Results 1888 subjects were randomised, 98.2% analysed (glycopyrronium=1059, tiotropium=267, placebo=528); male: 71.5%, mean age: 63.9 years, mean post-bronchodilator FEV1: 55.5% predicted. All trough FEV1 and FVC values for glycopyrronium and tiotropium were significantly greater than placebo (p<0.001) and glycopyrronium was numerically higher than tiotropium at all time-points (table).

The improvement in FEV1 with glycopyrronium was seen immediately after the first dose on Day 1 (90mL at 5min and 144mL at 15min versus placebo, p<0.001) and sustained throughout the 52 Week period. FEV1 AUC for 0–4h, 0–12h, 0–24h and 12–24h for glycopyrronium was significantly greater than placebo (p<0.05). AUC 0–4h for glycopyrronium was significantly greater than tiotropium on Day 1 and Weeks 12 and 26; all other AUC values for glycoprrronium were numerically higher than tiotropium.

Conclusion Once-daily glycopyrronium provided rapid, sustained and clinically meaningful bronchodilation over 52 weeks with efficacy similar to tiotropium in patients with COPD.

Abstract S50 Table 1

Trough FEV1 and FVC least square mean treatment difference (SE) from placebo (mL)

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