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. 2015 Jan 10;2015(1):CD010139. doi: 10.1002/14651858.CD010139.pub2

To 2011.

Methods Design: parallel, open‐label, randomised, controlled trial. 52 weeks' duration. Modified intention‐to‐treat analysis. Japanese participants
Run‐in: not stated
Participants Population: 186 participants with a diagnosis of moderate to severe COPD were randomly assigned. Mean age was 68 years
Inclusion criteria: adults > 40 years with at least a 20‐pack‐year smoking history
FEV1/FVC < 0.7, FEV1 30% to 80% predicted post bronchodilator
Exclusion criteria: respiratory tract infection or COPD exacerbation during previous 6 weeks, diagnosis of asthma, concomitant pulmonary disease, type 1 or uncontrolled type 2 diabetes, cancer with less than 5‐year survival, lung cancer, certain cardiovascular co‐morbidities
Interventions 1. Indacaterol 300 mcg
2. Salmeterol 50 mcg
Outcomes Primary outcome: blood glucose, QTc, serum potassium, blood pressure and pulse rate, other adverse events
Secondary outcome: trough FEV1
Follow‐up weeks 4, 8, 12, 24, 36, 44 and 52
Notes Unpublished trial; unable to obtain further data
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of randomisation was unclear
Allocation concealment (selection bias) High risk Open‐label trial
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label trial
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Method of blinding of outcome assessment was unclear
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Similar rates of dropout in both arms for similar reasons
Selective reporting (reporting bias) Low risk All prespecified outcomes were reported