Aclidinium bromide/formoterol fumarate fixed-dose combination for the treatment of chronic obstructive pulmonary disease.

INTRODUCTION: Combining a long-acting β(2)-agonist (LABA) and a long-acting antimuscarinic agent (LAMA) is potentially a good pharmacological approach to improve clinical results in stable moderate chronic obstructive pulmonary disease (COPD) patients when symptoms are not adequately controlled with tiotropium monotherapy. Consequently, there is a strong interest in developing a LABA/LAMA fixed-dose combination therapy in an attempt to simplify the treatment. AREAS COVERED: An aclidinium bromide/formoterol fumarate fixed-dose combination is under development. The few clinical data at our disposal suggest that the addition of formoterol fumarate to aclidinium bromide results in greater bronchodilation than formoterol fumarate or aclidinium bromide alone. However, a large Phase III program is involving a huge number of patients with moderate-to-severe COPD and consists of large long-term (from 24 to 52 weeks) pivotal clinical trials that have been designed to fulfil both European Medicines Agency (EMA) and Food and Drug Administration (FDA) requirements and are evaluating the efficacy and safety of this fixed-dose combination. EXPERT OPINION: Studies assessing the impact of aclidinium bromide/formoterol fumarate fixed-dose combination on COPD exacerbations, exercise capacity and hospitalisations are clearly needed to better detect its potential effects of disease modification in COPD. Moreover, it seems pragmatic to proceed with its introduction in the market at a highly competitive price.