Efficacy and safety of four doses of glycopyrrolate/formoterol fumarate delivered via a metered dose inhaler compared with the monocomponents in patients with moderate-to-severe COPD
International Journal of COPD Jun 25, 2018
Reisner C, et al. - In this Phase IIb, randomized, double-blind, balanced incomplete-block, two-period, cross-over study in patients with moderate-to-severe COPD, researchers assessed the efficacy and safety of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI 36/9.6, 36/7.2, 18/9.6, 9/9.6 μg) using innovative co-suspension delivery technology, compared with glycopyrrolate (GP) MDI 36 μg and formoterol fumarate (FF) MDI 9.6 μg. They found that for forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0–12) on Day 7, all doses of GFF MDI demonstrated superiority over GP MDI 36 μg. However, findings did not indicate the superiority of GFF MDI to FF MDI 9.6 μg. No clear dose-response was observed. No unexpected safety concerns arose and good tolerability of all treatments was reported.
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