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Randomised controlled trial
In two parallel pragmatic equivalence trials, leukotriene receptor antagonists as initial therapy for asthma compared with inhaled corticosteroids and as add on therapy to ICS compared with adding long-acting β agonists provided equivalent short-term asthma quality of life but were associated with more medication switches
  1. J Mark FitzGerald
  1. Centre for Lung Health, Institute for Heart and Lung Health, University of British Columbia, Canada
  1. Correspondence to J Mark FitzGerald
    Centre for Lung Health, Institute for Heart and Lung Health, University of British Columbia, 2775 Laurel Street, Vancouver, BC V5Z1M9, Canada; mark.fitzgerald{at}

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Asthma is a common condition for which there are robust evidence-based guidelines.1 Such guidelines are by definition based on the gold standard of randomised controlled trials (RCTs) which often have restrictive, inclusion and exclusion criteria, such that patients enrolled are not representative of patients seen in real world settings. Pragmatic trial designs have been suggested as a method of overcoming some of these limitations.2


In two parallel, multicentre open-labelled pragmatic trials, Price and colleagues evaluated the effectiveness of inhaled corticosteroids (ICS) versus leukotriene receptor antagonists (LTRAs) as initial asthma therapy (in trial 1) and the addition of an LTRA or a long-acting β agonist (LABA), by random allocation, for participants who remained uncontrolled after 12 weeks of ICS (in trail 2). Participants with physician-diagnosed asthma were recruited from 53 primary care practices in the UK. The study was not funded by the …

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  • Competing interests Yes – JMFG has received fees from AstraZeneca, GSK, Merck, BI and Novartis and Nycomed for lectures, advisory committees, travel grants or consultancy services. He has also received fees or grants paid and used for research, education, equipment or salaries from GSK, BI, Wyeth, Genentech, Topigen, Canadian Institute for Health Research, Medimmune, Pharmaxis, Novartis and AllerGen NCE. Finally, he does not have shares in the asthma-related pharmaceutical/medical device industry, excluding pension plans, mutual funds or unit trusts..