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. 2014 Sep 19;2014(9):CD010509. doi: 10.1002/14651858.CD010509.pub2

NCT01636401.

Methods Study design: placebo controlled, phase III study
Study duration: 12 weeks
Study centre and location: Seoul National University Hospital, Republic of Korea
Date of study: August 2012 to May 2013
Participants Inclusion criteria: male or female ≥ 40 years, current or former smokers with a cigarette smoking history of at least 10 pack‐years, diagnosed with stable, moderate to severe COPD as defined by the GOLD (post‐bronchodilator FEV1/FVC ratio < 70% and FEV1 ≥ 30% to < 80% of the predicted value)
 Exclusion criteria: history of or current asthma, hospitalisation for an acute COPD exacerbation within three months prior to the first visit, any respiratory tract infection or COPD exacerbation in the six weeks before first visit, clinically significant respiratory conditions other than COPD
Interventions Intervention: inhaled aclidinium bromide 400 μg twice daily
Comparison: matching placebo twice daily
Outcomes Primary outcome: change from baseline in morning predose (trough) FEV1 at week 12
Secondary outcome: change from baseline in peak FEV1 at week 12
Notes Source of support: Daewoong Pharmaceutical Co Ltd