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Dose-related efficacy of GSK573719, a new long-acting muscarinic receptor antagonist (LAMA) offering sustained 24-hour bronchodilation, in COPD

Marc Decramer, Francois Maltais, Gregory Feldman, Jean Brooks, Lisa Willits, Stephanie Harris, Glenn Crater
European Respiratory Journal 2011 38: p878; DOI:
Marc Decramer
1Respiratory Division, University Hospital, University of Leuven, Leuven, Belgium
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Francois Maltais
2Institut Universitaire de Cardiologie et de Pneumologie, Faculté de Médecine, Université Laval, Laval, Canada
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Gregory Feldman
3Research, S. Carolina Pharmaceutical, Spartanburg, United States
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Jean Brooks
4Respiratory Medicines Development Centre, GlaxoSmithKline, Uxbridge, United Kingdom
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Lisa Willits
5Respiratory Medicines Development Centre S&P, GlaxoSmithKline, Uxbridge, United Kingdom
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Stephanie Harris
6Medicines Development Centre, GlaxoSmithKline, Rearch Triangle Park, United States
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Glenn Crater
7Respiratory and Immuno-Inflammation Medicine Development Center, GlaxoSmithKline, Rearch Triangle Park, United States
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Abstract

Introduction: GSK573719 is an inhaled LAMA with sustained 24-hour activity under development as a once-daily therapy for COPD.

Objective: To evaluate the dose response of GSK573719 in patients with COPD.

Methods: This was a multicentre, randomised, double-blind, placebo-controlled, parallel-group study evaluating GSK573719 administered once daily via a novel single-step activation dry powder inhaler in patients with COPD (FEV1 of ≥35 and ≤70% predicted). The primary endpoint was morning pre-dose (trough) FEV1 after 28 days of treatment.

Results: All doses of GSK573719 significantly increased trough FEV1 compared with placebo, with improvement ranging from 150 to 168mL (p<0.001). All doses significantly increased 0–6 hour weighted mean FEV1 compared with placebo with differences ranging from 113 to 211mL (p<0.001). Additionally, all doses demonstrated significant improvements over placebo in serial FEV1 at each measured time point over 24 hours (p≤0.038). Reductions in albuterol use and improvements in FVC were also noted for all doses. All doses were well tolerated.

Conclusion: Once-daily dosing with GSK573719 provides clinically significant and sustained improvement in lung function and is well tolerated over 24 hours in patients with COPD.

Funded by GSK (AC4113589; NCT01030965)

  • © 2011 ERS
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Dose-related efficacy of GSK573719, a new long-acting muscarinic receptor antagonist (LAMA) offering sustained 24-hour bronchodilation, in COPD
Marc Decramer, Francois Maltais, Gregory Feldman, Jean Brooks, Lisa Willits, Stephanie Harris, Glenn Crater
European Respiratory Journal Sep 2011, 38 (Suppl 55) p878;

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Dose-related efficacy of GSK573719, a new long-acting muscarinic receptor antagonist (LAMA) offering sustained 24-hour bronchodilation, in COPD
Marc Decramer, Francois Maltais, Gregory Feldman, Jean Brooks, Lisa Willits, Stephanie Harris, Glenn Crater
European Respiratory Journal Sep 2011, 38 (Suppl 55) p878;
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