Kornmann 2011.

Methods	Design: double‐blind, parallel, randomised, controlled trial. 26 weeks' duration. Additional inhaled bronchodilators other than albuterol were discontinued. Patients were recruited from Canada, Europe, South America, India and Taiwan Run‐in: 2 weeks
Participants	Population: 1002 participants with a diagnosis of moderate to severe COPD were randomly assigned. Mean age 63 years. In the indacaterol 150 mcg, salmeterol 50 mcg and placebo arms, 45%, 46% and 40% were taking concomitant inhaled corticosteroids, respectively. Mean FEV1 was 54%, 53% and 53%, respectively Inclusion criteria: age > 40, smoking history > 20 pack‐years, 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, long‐term oxygen therapy, type 1 or uncontrolled type 2 diabetes, cancer with less than 5‐year survival, lung cancer, QTc abnormalities, shift workers
Interventions	1. Indacaterol 150 mcg 2. Salmeterol 50 mcg 3. Placebo
Outcomes	Primary endpoint: 24‐hour postdose trough FEV1 after 12 weeks. Other endpoints: SGRQ, Transitional Dyspnoea Index (TDI), symptom diaries, use of as needed salbutamol Follow‐up at day 2, weeks 4, 8, 12, 26 Values reported at baseline; additional information obtained from study authors for post‐treatment data
Notes	Study was supported by Novartis, and some authors were Novartis employees. Novartis directly supplied data for: Indacaterol versus placebo (number of participants experiencing at least one exacerbation); Indacaterol versus LABA (dyspnoea, number of participants experiencing at least one exacerbation).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomly allocated to treatment using an automated system
Allocation concealment (selection bias)	Low risk	Allocation via automated system, double‐dummy design
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Allocated interventions were not known by participants or personnel during the study; placebo appears adequate
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcome assessors were blinded to treatment allocation
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Higher dropout rates in placebo arm were largely due to withdrawal of consent or unsatisfactory therapeutic effect
Selective reporting (reporting bias)	Low risk	All outcomes were reported, not just statistically significant outcomes