Kinoshita 2012.

Methods	Design: 12‐week, multi‐centre, randomised, double‐blind, placebo‐controlled, parallel‐group study. Participants were recruited from Asian countries including Japan. Additional inhaled bronchodilators other than albuterol were discontinued. Run‐in: not specified
Participants	Population: 347 participants were randomly assigned. Mean age 66.7 years. Mean FEV1 was 53.7%. In the indacaterol 150 mcg, indacaterol 300 mcg and placebo arms, 22%, 22% and 23% of participants were taking concomitant inhaled corticosteroids, respectively Inclusion criteria: adults > 39 years with at least 20‐pack‐year smoking history FEV1 < 80% > 29%, FEV1/FVC < 70% Exclusion criteria: lower respiratory tract infection or hospitalisation with an acute exacerbation of COPD within the previous 6 weeks, requirement for long‐term oxygen therapy, asthma, any alternative significant cardiovascular or respiratory disease, type 1 or poorly controlled type 2 diabetes, history of long QT syndrome or prolonged QTc, history of vaccination with live attenuated vaccines within the previous 30 days or during the run‐in period
Interventions	1. Indacaterol 150 mcg 2. Indacaterol 300 mcg 3. Placebo
Outcomes	Primary outcome: 12‐week trough FEV1 Secondary outcomes:‐ trough FEV1 at weeks 2, 4, 8, individual time point FEV1 and FVC on day 1, peak FEV1 on day 1 Other outcomes: health status, diary cards, dyspnoea, rescue medication, safety and tolerability
Notes	Trial was sponsored by Novartis, which assisted in preparation of the manuscript. Novartis directly supplied data for: trough FEV1, dyspnoea, peak FEV1, number of participants experiencing at least one exacerbation.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation using a validated automated system
Allocation concealment (selection bias)	Unclear risk	Allocation via an automated system, although the method of allocation concealment was not specified. Matching placebo was used
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Participant, caregiver, investigator, outcomes assessor were all blinded, and matching placebo was used
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinded outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	Higher rate of attrition from placebo arm, primarily due to adverse events
Selective reporting (reporting bias)	Low risk	All prespecified outcomes were reported