Clinical trials and tribulations: the MASCOT study

Warren Lenney, Sophie Perry, David Price

Research output: Contribution to journalEditorial

16 Citations (Scopus)

Abstract

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.
Original languageEnglish
Pages (from-to)457-458
Number of pages2
JournalThorax
Volume66
Issue number6
Early online date11 Mar 2011
DOIs
Publication statusPublished - Jun 2011

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