A randomized study of formoterol fumarate in a porous particle metered-dose inhaler in patients with moderate-to-severe COPD

Summary Background Formoterol fumarate (FF) is a well-established long-acting β2 -agonist. This represents the first clinical study of FF in a metered-dose inhaler (FF MDI) based on proprietary lipid-based porous-particle engineering technology. Methods In this randomized, double-blind, 5-period, crossover study ( NCT00880490 ), subjects received 2.4, 4.8, and 9.6 μg of FF MDI, open-label Foradil® Aerolizer® (FA) 12 μg, and placebo. Spirometry was performed at baseline, 15 and 30 min, and 1, 2, 4, 6, 8, 10, 11.5, and 12 h post-dose. Results Thirty-four subjects were enrolled. Improvement in forced expiratory volume in 1 s (FEV1 ) was similar between FF MDI 9.6 μg and FA. Change in FEV1 area under the curve for 0–12 h (AUC0–12 ) for each FF MDI dose demonstrated superior efficacy versus placebo ( P