Inhaled Glycopyrronium Improves Lung Function in COPD Patients
Phase II study evaluates once-daily, orally inhaled monotherapy (January 23)
Positive results have been reported from a phase II study of PSX1002 (Prosonix) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
PSX1002 is a particle-engineered, drug-only suspension formulation of a long-acting muscarinic antagonist (LAMA), glycopyrronium bromide, which is being develop as a potential once-daily, orally inhaled monotherapy for COPD.
The randomized, double-blind, single-dose study investigated the effects on expiratory lung function, tolerability, and safety of a range of doses of orally inhaled PSX1002 versus placebo delivered via a pressurized metered-dose inhaler in male and female patients with moderate-to-severe COPD; 37 patients were entered into the study, and 33 completed all five dosing sessions.
The study met its primary endpoint of demonstrating that a range of doses of PSX1002 improved lung function in COPD patients compared with placebo. An analysis of the primary endpoint (mean adjusted forced expiratory volume in 1 second [FEV1] area under the curve [AUC0–24h] post-dose) demonstrated statistically significant separation from placebo for all doses, with a clear progression of effect by dose.
Source: Prosonix; January 23, 2014.