The study was managed by CROMSOURCE on behalf of a mid-sized European pharmaceutical client. The trial involved 212 sites in 14 countries across all regions of Europe. CROMSOURCE was tasked with screening 2,404 subjects with controlled asthma to recruit 1,682 randomised subjects in a period of 9 months.
The primary efficacy endpoint of the study was the time to first severe asthma exacerbation. Centralised blood exams, ECG, and spirometry were performed using different vendors.
Study drug management (packaging, labelling, storage, distribution, and central randomisation) was supported by a specialised vendor, considering the critical need to maintain tight temperature control during shipment.
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