Clinical investigation Design: A phase III, 2 arm, multi-centre, open label, parallel-group, individually randomised clinical investigation
Objectives: Our overall ambition is clinical validation and commercialisation of the COPDPredictTM to guide and support chronic obstructive pulmonary disease (COPD) patients in identifying exacerbations early, leading to a reduction in total acute exacerbations of COPD (AECOPD)-induced hospital admissions in the 12 months following each patients randomisation. Using a multi-skills team approach, we aim to complete the trial over 27 months.
The aim is to assess:
1) The clinical-effectiveness of COPDPredictTM (with regard to hospitalisation rate over the course of a year)
2) The cost- effectiveness of COPDPredictTM (in terms of whether patients use more or less health resources to manage their COPD)