Kerwin EM, et al. - In this Phase IIb, randomized, double-blind, four-period, five-treatment, incomplete-block, crossover study, researchers assessed the efficacy, safety, and pharmacokinetics of the inhaled corticosteroid/long-acting β₂-agonist fixed-dose combination budesonide/formoterol fumarate (BFF) metered dose inhaler (MDI), relative to the monocomponents budesonide (BD) MDI and formoterol fumarate (FF) MDI, in patients with moderate-to-severe COPD. The treatment regimen included BFF MDI 320/9.6 μg and FF MDI 9.6 μg, and two of either BFF MDI 160/9.6 μg, BFF MDI 80/9.6 μg, or BD MDI 320 μg twice daily for 28 days. Significantly improved forced expiratory volume in 1 second area under the curve from 0 to 12 hours on Day 29 was achieved with all BFF MDI doses vs BD MDI 320 μg, and with BFF MDI 320/9.6 μg vs FF MDI 9.6 μg. Overall, data corroborated that BFF MDI 320/9.6 μg is an appropriate dose to take forward into Phase III studies in patients with COPD.