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Two new findings using data from the ISOLDE trial are presented in this issue of Thorax: (1) patients with COPD cannot be separated into discrete corticosteroid responders and non-responders, and (2) the response of an individual patient with COPD to a bronchodilator challenge on a single occasion does not predict whether or not the patient will benefit subsequently from that agent. Consistency is needed between North America and Europe as to the diagnosis of COPD and the criteria for inclusion in COPD trials.
The main results of the ISOLDE trial have been published1 and are now part of the canon of knowledge about COPD—inhaled corticosteroids (ICS) do not change the rate of decline of FEV1 in COPD. This finding is consistent with that of other similar large long term trials,2–4 so the question has been settled. As in some of the other studies, there may be decreases in the frequency and severity of acute exacerbations, and quality of life may be modestly improved. These questions are being addressed in separate ongoing long term trials.
Despite the rule that the primary and secondary outcomes of a trial must be prestated and set in stone in the protocol, trials such as ISOLDE are so large and so carefully planned, executed, and monitored that the huge amounts of data they generate offer many opportunities to examine questions other than the prestated outcomes—questions that are scientifically important but which are unlikely ever to find funding as primary outcomes. In the absence of any methodological aspect of the trial that would invalidate it from being used to answer a different question, it is appropriate to mine the data for any and all other useful information they may provide. Sometimes disparaged as “data dredging”, the meticulous review of the data for …
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