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Outcomes in clinical trials of inhaled corticosteroids for children with asthma are narrowly focussed on short term disease activity.

Sinha, IP; Williamson, PR; Smyth, RL; (2009) Outcomes in clinical trials of inhaled corticosteroids for children with asthma are narrowly focussed on short term disease activity. PLOS One , 4 (7) , Article e6276. 10.1371/journal.pone.0006276. Green open access

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Abstract

Little work has been done to determine which outcomes should be measured in randomised controlled trials (RCTs) in children with asthma. Drug regulatory authorities require that short term disease activity is measured, but other outcome domains are not mandatory for licensing and marketing purposes. We aimed to identify whether any domains were underrepresented in RCTs of regular therapies for children with asthma over a 20 year period, and to examine what consistency there was between RCTs in the outcomes used to assess the domains.

Type: Article
Title: Outcomes in clinical trials of inhaled corticosteroids for children with asthma are narrowly focussed on short term disease activity.
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1371/journal.pone.0006276
Publisher version: http://dx.doi.org/10.1371/journal.pone.0006276
Language: English
Additional information: © 2008 Sinha et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Ian Sinha is funded by the NIHR Medicines for Children Research Network Clinical Trials Unit and Co-ordinating Centre. The Medicines for Children Research Network is part of the National Institute for Health Research (NIHR), and is funded by the Department of Health. The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript.
Keywords: Administration, Inhalation, Adrenal Cortex Hormones, Asthma, Child, Follow-Up Studies, Humans, Randomized Controlled Trials as Topic, Treatment Outcome
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL GOS Institute of Child Health > Infection, Immunity and Inflammation Dept
URI: https://discovery.ucl.ac.uk/id/eprint/1375482
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