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Aims  To establish the dose−response for pharmacodynamics (bronchodilatation), safety and pharmacokinetics for a nebulized formulation of the long acting muscarinic antagonist glycopyrrolate ( EP ‐101) with a high efficiency nebulizer in patients with chronic obstructive pulmonary disease ( COPD ).    Methods  Patients with moderate to severe  COPD  ( GOLD II / III ), with reversible lung function, were enrolled into this randomized, double‐blind, placebo‐controlled, six period crossover study ( n  = 42). Patients received single doses of  EP ‐101 (12.5–400 μg) and placebo via a high efficiency nebulizer (eFlow®  PARI  nebulizer), with washout between treatments. Plasma pharmacokinetics were assessed in a subset of patients ( n  = 11).    Results  All treatments were well tolerated with similar adverse event rates reported with placebo and at all doses. There were no clinically relevant changes in heart rate, systolic and diastolic blood pressure or in  ECG  parameters including  QT c   interval. Following treatment with  EP ‐101 at all doses there was a rapid bronchodilator response within 5 min. Significant improvements in mean change from baseline  FEV 1   at 24 h were reported at doses ≥50 μg compared with placebo, with a clear dose−response relationship. Mean changes in  FEV 1   were 0.10 l (95%  CI  0.06, 0.14) and 0.12 l (95% CI 0.08, 0.16) for 100 μg and 200 μg, respectively.    Conclusion  Single doses of  EP ‐101 ranging from 12.5 μg to 400 μg were well tolerated.  EP ‐101 delivered by high efficiency nebulizer device produced a rapid onset of bronchodilatation with clinically meaningful improvements in lung function maintained over a 24 h period at all doses >50 μg.

british journal of clinical pharmacology

Efficacy and safety of nebulized glycopyrrolate for administration using a high efficiency nebulizer in patients with chronic obstructive pulmonary disease