Asthma Clinical Trial
Official title:
A Double-blind, Double Dummy, Randomised, Parallel Group, Multicentre Study to Compare the Efficacy and Safety of Flutiform pMDI With Fluticasone pMDI and With Seretide pMDI in Paediatric Subjects Aged 5 to Less Than 12 Years With Moderate to Severe Persistent Reversible Asthma
This is a comparator study to assess safety and efficacy of Flutiform compared with Fluticasone pMDI and Seretide pMDI in paediatric asthma patients with moderate to severe persistent, reversible asthma.
This is a study involving a 2-4 week run-in phase followed by a 12 week double blind treatment phase. During the run-in phase, all subjects receive Flixotide. In the treatment phase subjects will be randomised to one of the 3 treatment groups and will receive active Flutiform and placebo Flixotide or Active Seretide and placebo Flixotide or active Flixotide and either placebo seretide or placebo Flutiform. Efficacy will be assessed by lung function tests, asthma symptoms, sleep disturbance due to asthma and rescue medication use. Safety will be assessed by adverse events, lab tests, urinary cortisol and vital signs. ;
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