New combinations in the treatment of COPD: rationale for aclidinium–formoterol

Figures & data

Table 1 Controlled trials on efficacy, safety, and tolerability of the FDC aclidinium–formoterol

Authors	Patients (n)	Duration	Aclidinium + formoterol (via Genuair/Pressair)	Control (via Genuair/Pressair)	Results	Safety and tolerability
Singh et al^Citation21	1,344	24 weeks	400+12 μg 400+6 μg	Placebo 400 μg 12 μg	Both FDCs significantly improved FEV1 from baseline in 1 hour postdose versus aclidinium, formoterol, and placebo. TDI score was significantly improved with aclidinium + formoterol. Aclidinium + formoterol FDC also improved bronchodilatation compared to monotherapy.	The incidence of TEAEs and SAEs was low and comparable in all groups. No significant differences between treatment groups in ECG, vital signs, and laboratory tests. There were four fatal events, none of which was considered to be related to treatments.
D’Urzo et al^Citation22	1,692	24 weeks	400+12 μg 400+6 μg	Placebo 400 μg 12 μg	Both FDCs improved FEV1 from baseline in 1 hour postdose compared to aclidinium, formoterol, and placebo. SGRQ total, TDI score, and EXACT-RS scores were improved with aclidinium + formoterol. Both FDCs reduced the use of rescue medications more than other monotherapies and placebo.	The overall incidence of AEs was low and comparable between both FDCs and placebo, while it was lower in monotherapy groups. SAEs and TEAEs were infrequent, and occurred with similar incidences in all groups. Five fatal events were reported, none of which was related to treatments.

Abbreviations: FDC, fixed-dose combination; FEV₁, forced expiratory volume in 1 second; TDI, Transition Dyspnea Index; TEAEs, treatment-emergent adverse events; SAEs, severe AEs; AEs, adverse events; ECG, electrocardiography; SGRQ, St George’s Respiratory Questionnaire; EXACT, Exacerbations of Chronic Pulmonary Disease Tool; RS, respiratory symptoms.

SinghDJonesPWBatemanEDEfficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised studyBMC Pulm Med20141417825404569

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D’UrzoADRennardSIKerwinEMMergelVLeselbaumARCaractaCFEfficacy and safety of fixed-dose combinations of aclidinium bromide/formoterol fumarate: the 24-week, randomized, placebo-controlled AUGMENT COPD studyRespir Res20141512325756831

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