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Counting, analysing and reporting exacerbations of COPD in randomised controlled trials
  1. J Vestbo
  1. North West Lung Centre, Wythenshawe Hospital, Manchester, UK; and Department of Cardiology and Respiratory Medicine, Hvidovre Hospital, Hvidovre, Denmark
  1. Dr J Vestbo, 2nd Floor ERC Building, Wythenshawe Hospital, Southmoor Road, Manchester M23 9LT, UK; jorgen.vestbo{at}manchester.ac.uk

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    I read with interest the article by Aaron et al.1 In this paper, data from the Optimal Trial2 were reanalysed for the purpose of examining the effect of differences in counting and analysing exacerbation rates on estimated treatment effects in chronic obstructive pulmonary disease (COPD). The authors compare exacerbation rates in two of the three treatment arms in the trial (ie, those randomly allocated to tiotropium + placebo or to tiotropium + fluticasone–salmeterol). They compare an “intention to treat” strategy with a strategy using “time in study only” …

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    Footnotes

    • Competing interests: JV has been involved in clinical trials of inhaled corticosteroid alone or in combination with long acting beta agonists; his wife is an employee of AstraZeneca.