Specific role of combination aclidinium: formoterol in the treatment of chronic obstructive pulmonary disease

Figures & data

Table 1 Phase III pivotal studies

Study	Design	Number of patients	Treatments	Results
Singh et al^Citation35	24-week double-blind, parallel-group, active- and placebo-controlled, multicenter study	1,729	Twice-daily ACLI/FORM FDC 400/12 µg or 400/6 µg, ACLI 400 µg, FORM 12 µg or placebo	Significant improvement with ACLI/FORM FDC 400/12 µg and 400/6 mL µg in 1 hour postdose FEV1 vs ACLI (125 and 69 respectively), trough FEV1 vs FORM (85 and 53 mL) and TDI focal score vs placebo (1.29 and 1.16 units) No statistically significant differences between active and placebo treatments in SGRQ total score, but a significantly higher proportion of patients receiving ACLI/FORM FDC 400/6 µg with ≥4 units decrease in SGRQ total score at week 24 vs placebo ACLI/FORM FDC 400/12 statistically superior to the ACLI/FORM FDC 400/6 µg in 1 hour postdose FEV1 Improvement numerically greater in trough FEV1 with ACLI/FORM FDC 400 vs ACLI
D’Urzo et al^Citation52	24-week double-blind, parallel-group, active- and placebo-controlled, multicenter study	1,692	Twice-daily ACLI/FORM FDC 400/12 or 400/6 µg, ACLI 400 µg, FORM 12 µg or placebo	Significant improvement with ACLI/FORM FDC 400/12 and 400/6 µg in 1 hour postdose FEV1 vs ACLI (108 and 87 mL, respectively), and with ACLI/FORM FDC 400/12 in trough FEV1 vs FORM (45 mL) Numerically greater improvement with ACLI/FORM FDC 400/6 µg in trough FEV1 vs FORM (26 mL) Numerically greater improvement in trough FEV1 with ACLI/FORM FDC 400/12 vs 400/6 µg Significant improvement with ACLI/FORM FDC 400/12 in TDI focal score vs FORM Numerically greater improvements in TDI focal scores compared to either monotherapy with ACLI/FORM FDC 400/12 and 400/6 µg Improvements in TDI focal scores similar between ACLI/FORM FDC 400/12 and 400/6 µg Significant improvements in SGRQ total scores with the ACLI/FORM FDCs and the monotherapies vs placebo Mean differences in SGRQ total score over placebo exceeded the MCID of 4 units in patients treated with ACLI/FORM FDC 400/12 µg or ACLI monotherapy

Abbreviations: ACLI, aclidinium bromide; FEV1, forced expiratory volume in 1 s; FDC, fixed-dose combination; FORM, formoterol fumarate; MCID, minimum clinically important difference; SGRQ, St George’s Respiratory Questionnaire; TDI, Transition Dyspnea Index.

SinghDJonesPWBatemanEDEfficacy and safety of acli-dinium 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’UrzoADRennardSIKerwinEMEfficacy 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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