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Editorial
Clinical trials and tribulations: the MASCOT study
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  1. Warren Lenney1,
  2. Sophie Perry2,
  3. David Price3
  1. 1University Hospital of North Staffordshire and Keele University, Academic Department of Child Health, Stoke-on-Trent, Staffordshire, UK
  2. 2Medicines for Children Research Network Clinical Trials Unit, Institute of Child Health, Alder Hey Hospital, Liverpool, UK
  3. 3Respiratory Primary Care, Centre of Academic Primary Care, University of Aberdeen, Foresterhill Health Centre, Westburn Road, Aberdeen, UK
  1. Correspondence to Professor Warren Lenney, University Hospital of North Staffordshire, Academic Department of Child Health, Stoke-on-Trent, Staffordshire ST4 6QG, UK; warren.lenney{at}uhns.nhs.uk

https://doi.org/10.1136/thx.2010.156885

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    Following the 1994 Lancet paper showing benefits of long-acting β-agonists (LABAs) in adults with asthma,1 British Paediatric Respiratory Society surveys have consistently recommended undertaking similar studies appropriately designed for children. Adult outcome measures should not be extrapolated into childhood, which explains why early studies indicated LABAs may be less helpful in children.2 With the advent of the Medicines for Children Research Network (MCRN) in 2004, the Health Technology Assessment (HTA) put out a call for children's medicines studies in 2005. The Management of Asthma in School Children On Therapy (MASCOT) study was funded in January 2006 pending Pharma approval to supply the medicines (fluticasone, fluticasone–salmeterol combination treatment and montelukast) as National Institute for Health Research funding does not include excess treatment costs. This task took 12 months including lengthy discussions with Merck, Sharp and Dome (MSD) about methodology and statistics.

    The MASCOT study

    The protocol required 900 children to use inhaled corticosteroids (ICS) for a 4 week open run-in followed by 48 weeks (double blind, double dummy) taking ICS, ICS plus LABA or ICS plus montelukast. The primary outcome measure was the exacerbation rate. The HTA funded MASCOT research costs. MSD and GlaxoSmithKline (GSK) agreed to supply medication. There was a delay in appointing a trial coordinator to oversee the 13 sites which had readily agreed to participate. The lengthy task of writing the protocol to EU standards (in addition to the original protocol designed for HTA application) was new and baffling to many of us, as was the preparation and submission of the Clinical Trials Authorisation.

    Study progress

    • No medicinal National Health Service (NHS) packaging company could undertake the complex arrangements to receive and package the medications and distribute them to the sites. So in December 2007 we returned to the HTA to request additional commercial …

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