Conclusions

W Lenney; AJ McKay; C Tudur Smith; PR Williamson; M James; D Price; MASCOT Study Group

Chapter 5Conclusions

Implications for health care

Unfortunately, the early cessation of this study leaves the question of how best to treat children uncontrolled on ICSs unanswered. Since commencing the MASCOT study an American asthma study, the BADGER trial,¹² has been published which concluded that long-acting beta-2 agonist step-up was more likely to provide a better response than either fluticasone alone or fluticasone plus montelukast. This is in keeping with the present national UK guidelines for asthma therapy.² Further studies that have compared add-on long-acting beta-2 agonist with doubling the dose of fluticasone in children²⁸^,²⁹ have favoured long-acting beta-2 agonist step-up. However, these studies have major limitations, such as short duration, required reversibility to be recruited and inappropriate outcome measures for children, which make it difficult to generalise the results. Now that MASCOT has been prematurely terminated, the question may never be adequately addressed.

Recommendations for research

We believe that there are two major priorities arising from this work. The first is to examine whether or not patients treated in primary care for a chronic condition can be approached by someone from outside their current care team to consider study participation.

Second, it is important to look at alternative study designs to answer the key research question of what is the most appropriate treatment for children uncontrolled on low-dose ICSs. This might be carried out using routine data included in primary care databases, possibly supplemented with patient-reported outcome data.

Setting the study in the context of existing research

Compared with the adult literature, the results of studies of asthma in children have been inconsistent, and there are far fewer studies available. The earlier studies, in particular, produced negative results⁵ and there was little information available for the Cochrane systematic review.³⁰ The MASCOT study, therefore, had the potential to be the definitive paper to state what is the appropriate treatment at step 3 of the national and international guidelines for asthma when low-dose ICSs are not successfully controlling symptoms and exacerbations. Failure to recruit sufficient numbers has prevented this study goal.

Publication Details

Copyright

Copyright © Queen's Printer and Controller of HMSO 2013. This work was produced by Lenney et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

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Publisher

NIHR Journals Library, Southampton (UK)

NLM Citation

Lenney W, McKay AJ, Tudur Smith C, et al.; MASCOT Study Group. Management of Asthma in School age Children On Therapy (MASCOT): a randomised, double-blind, placebo-controlled, parallel study of efficacy and safety. Southampton (UK): NIHR Journals Library; 2013 Feb. (Health Technology Assessment, No. 17.4.) Chapter 5, Conclusions.