Kerwin 2011 Study 2.

Methods	Design: 12‐week, double‐blind, randomised, placebo‐controlled trial. 1 arm of 2 identical trials, with analysis performed on combined population of the trials. Additional inhaled bronchodilators other than albuterol were discontinued. Run‐in: 2 weeks
Participants	Population: 323 participants were randomly assigned. Mean age 64 years. In the indacaterol and placebo arms, 43% and 48% of participants were taking concomitant ICS, respectively, and mean FEV1 was 54% and 53%, respectively Inclusion criteria: > 40 years of age, at least a 10‐pack‐year smoking history FEV1 < 80% and > 29% FEV1/FVC < 70% post 360 mcg albuterol Exclusion criteria: lower respiratory tract infection or hospitalisation with an acute exacerbation of COPD within previous 6 weeks, asthma, any alternative significant cardiovascular or respiratory disease, type 1 or poorly controlled type 2 diabetes, history of long QT syndrome or prolonged QTc. Inhaled anticholinergic medications were not permitted
Interventions	1. Indacaterol 75 mcg once daily 2. Placebo
Outcomes	Primary outcome: trough FEV1 at 12 weeks Secondary outcomes: other spirometric variables, use of rescue albuterol, health status (SGRQ), dyspnoea (TDI), exacerbations, diary card symptom scores
Notes	Novartis sponsored trial, and Novartis employees were directly involved in preparation and drafting of the manuscript. Novartis directly supplied data for: trough FEV1, quality of life, 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	Automated random assignment via active voice response/web system
Allocation concealment (selection bias)	Low risk	Participants and investigating staff were blinded to treatment allocation from randomisation to study completion; probably done
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Placebo and indacaterol were administered via identical inhalers
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Persons performing outcome assessments were blinded to allocations
Incomplete outcome data (attrition bias) All outcomes	Low risk	Roughly comparable dropout rate, similar reasons for dropouts across groups, rates of dropout slightly higher in the placebo group
Selective reporting (reporting bias)	High risk	Dyspnoea and other subjective endpoints were secondary outcomes that were not reported in published data or were reported with minimal detail (although some data are available from Novartis)