A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease

BACKGROUND: Long-acting muscarinic antagonist/long-acting beta2-agonist combinations are recommended for patients whose chronic obstructive pulmonary disease (COPD) is not managed with monotherapy. We assessed the efficacy and safety of glycopyrrolate (GP)/formoterol fumarate (FF) fixed-dose combination delivered via a Co-Suspension Delivery Technology-based metered dose inhaler (MDI) (GFF MDI). METHODS: This was a Phase IIb randomized, multicenter, placebo-controlled, double-blind, chronic-dosing (7 days), crossover study in patients with moderate-to-very severe COPD ( NCT01085045 ). Treatments included GFF MDI twice daily (BID) (GP/FF 72/9.6 mug or 36/9.6 mug), GP MDI 36 mug BID, FF MDI 7.2 and 9.6 mug BID, placebo MDI, and open-label formoterol dry powder inhaler (FF DPI) 12 mug BID or tiotropium DPI 18 mug once daily. The primary endpoint was forced expiratory volume in 1 s area under the curve from 0 to 12 h (FEV1 AUC0-12) on Day 7 relative to baseline FEV1. Secondary endpoints included pharmacokinetics and safety. RESULTS: GFF MDI 72/9.6 mug or 36/9.6 mug led to statistically significant improvements in FEV1 AUC0-12 after 7 days' treatment versus monocomponent MDIs, placebo MDI, tiotropium, or FF DPI (p

Reisner, C.

Fabbri, L. M.

Kerwin, E. M.

Fogarty, C.

Spangenthal, S.

Rabe, K. F.

Ferguson, G. T.

Martinez, F. J.

Donohue, J. F.

Darken, P.

St Rose, E.

Orevillo, C.

Strom, S.

Fischer, T.

Golden, M.

Dwivedi, S.