To 2011.
Methods |
Design: parallel, open‐label, randomised, controlled trial. 52 weeks' duration. Modified intention‐to‐treat analysis. Japanese participants Run‐in: not stated |
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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 |
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Interventions | 1. Indacaterol 300 mcg 2. Salmeterol 50 mcg |
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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 |
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Notes | Unpublished trial; unable to obtain further data | |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 |