Mroz 2013.
Methods |
Design: 12‐week, randomised, controlled trial. Population analysed was not specified. Number of centres was not specified. Alternative inhaled long‐acting beta2‐agonists were ceased. Use of alternative inhaled bronchodilators was not specified Run‐in: not specified |
|
Participants | Population: 34 predominantly male participants with a diagnosis of COPD were randomly assigned with 17 participants in each arm (spirometric criteria and method of diagnosis of COPD not specified). Mean age 63 years. Other baseline characteristics were not specified | |
Interventions | 1. Indacaterol 300 mcg 2. Placebo |
|
Outcomes | Spirometry, lung volumes, diffusing capacity for carbon monoxide, SGRQ, 6‐minute walk distance (6MWD) and 6MWD‐related dyspnoea and fatigue scores and arterial blood oxygen saturation were performed at 4, 8 and 12 weeks | |
Notes | Authors directly supplied data for: trough FEV1 and quality of life. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Method of randomisation was not specified. Placebo and experimental arms were poorly matched with respect to lung function at the start of the trial, with higher lung function reported in the indacaterol arm, raising the suggestion of inadequate sequence generation |
Allocation concealment (selection bias) | High risk | Method of allocation was not specified |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Method of blinding was not specified. Unclear whether a placebo inhaler device was used |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear who performed outcome assessments and whether they were blinded to treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropouts were not reported |
Selective reporting (reporting bias) | Low risk | Diffusing capacity of carbon monoxide was not reported. Otherwise all outcomes were reported |