Lakhasly

Secondary outcomes: Change from baseline in peak FEV1 of aclidinium bromide 400 ug compared to placebo at week 24.Change from baseline in morning predose (trough) FEV1 of FDC 400/12 ug compared to formoterol fumarate at week 24.Improvements TDI focal score of FDC 400/12 ug and aclidinium bromide 400 ug compared to placebo at week 24.Change from baseline in trough FEV1 of aclidinium bromide 400 ug compared to placebo at week 24.Change from baseline in SGRQ total score of FDC 400/12 ug and aclidinium bromide 400 ug compared to placebo at week 24

Exclusion criteria: history or current diagnosis of asthma; any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation (including the mild COPD exacerbation) within 6 weeks prior to screening or during the run‐in period; hospitalised for COPD exacerbation (emergency department visit for > 24 hours will be considered a hospitalisation) within 3 months prior to screening and during the run‐in period; clinically significant respiratory conditions other than COPD; people who need to start a pulmonary rehabilitation programme during the study or people who started/finished it within 3 months prior to screening; use of long‐term oxygen therapy (≥ 15 hours/day); clinically significant cardiovascular conditions; QT corrected interval (QTc) > 470 mseconds at screening; malignancy and clinically significant medical illnesses; clinically significant abnormalities in the laboratory tests, ECG parameters (other than QTc) or in the physical examination at screening; history of hypersensitivity to inhaled anticholinergics
Intervention: inhaled FDC aclidinium bromide 400 μg/formoterol fumarate 12 μg twice daily via Genuair
Comparison: inhaled aclidinium bromide 400 μg twice daily via Genuair, inhaled formoterol fumarate 12 μg twice daily via Turbuhaler, Inhaled placebo twice daily via Genuair or via Turbuhaler
Primary outcomes:
Change from baseline in 1‐hour morning postdose FEV1 of FDC 400/12 μg compared to aclidinium bromide at week 24.
Change from baseline in morning predose (trough) FEV1 of FDC 400/12 μg compared to formoterol fumarate at week 24.
Change from baseline in trough FEV1 of aclidinium bromide 400 μg compared to placebo at week 24.
Secondary outcomes:
Change from baseline in peak FEV1 of aclidinium bromide 400 μg compared to placebo at week 24.
Improvements TDI focal score of FDC 400/12 μg and aclidinium bromide 400 μg compared to placebo at week 24.
Change from baseline in SGRQ total score of FDC 400/12 μg and aclidinium bromide 400 μg compared to placebo at week 24