Introduction Combinations of different classes of medication used in the management of chronic obstructive pulmonary disease (COPD) may provide additional improvements compared with monotherapy. This study assessed the efficacy and safety of aclidinium bromide 200 μg, a novel long-acting muscarinic antagonist, combined with formoterol, a long-acting β-agonist. All combination and monotherapy treatments were delivered as single inhalations.
Methods 566 patients with moderate to severe COPD were randomised in a double-blind manner to receive aclidinium plus formoterol 6 μg (n=121), 12 μg (n=120) or 18 μg (n=125), or monotherapy with aclidinium (n=76), formoterol 12 μg (n=65) or placebo (n=59). Treatment was administered once-daily for 4 weeks via the Genuair® inhaler, a multidose dry powder inhaler. The primary efficacy endpoint was change from baseline in normalised forced expiratory volume in 1 second (FEV1) area under the curve over 12 h (AUC0–12h) at 4 weeks. Safety was assessed throughout the study.
Results There was a mean (±SE) increase from baseline in normalised FEV1 AUC0–12h at 4 weeks with aclidinium plus formoterol 6, 12 or 18 μg (0.170±0.022, 0.219±0.22 and 0.230±0.022 l, respectively), and aclidinium (0.075±0.027 l) and formoterol (0.099±0.031 l) monotherapy. No improvement was observed in the placebo group. All combinations were significantly superior to placebo (p<0.0001) and to both monotherapies (p<0.001), except for the comparison between aclidinium and formoterol 6 μg and formoterol 12 μg monotherapy. Mean change from baseline in 12-h FEV1 at 4 weeks is shown in the figure. Aclidinium plus formoterol 6, 12 or 18 μg was well-tolerated with a safety profile similar to that observed with monotherapy or placebo.
Conclusions Aclidinium combined with formoterol provided greater improvements in pulmonary parameters than either drug alone or placebo. The bronchodilation provided by aclidinium and formoterol 18 μg was comparable to aclidinium and formoterol 12 μg, suggesting the optimal dose of formoterol was 12 μg. No safety concerns arose during the study. These findings support the combination of aclidinium and formoterol for the treatment of COPD.
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Funding This study was supported by Almirall S.A., Barcelona, Spain, and Forest Laboratories, Inc., New York, USA.
Genuair® is a registered trademark of Almirall S.A.
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