Imperial College Healthcare NHS Trust (ICHT)

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The EXHALE programme is a group of phase 3 studies which are testing the efficacy, safety of oral dexpramipexole in subjects with moderate to severe or severe eosinophilic asthma.

There are 5.4 million people being treated for asthma in the UK and about 17% of these have difficult to control asthma which means they experience difficulty breathing nearly every day.1 Around 1,400 asthma deaths occurred in the UK in 2018.2 The National Review of Asthma Deaths concluded that 46% of these deaths were avoidable with treatment, and that 57% of those who died were not accessing specialist asthma care.3 Asthma also represents a significant burden of disability and negative impact on patient quality of life. Globally, asthma is ranked 16th among the leading causes of years lived with disability.4 Increasing age, lower educational level, poorer asthma control and requiring hospital admission were all significantly associated with poorer health-related quality of life in asthma patients.6 The EXHALE programme is a group of phase 3 studies which are testing the efficacy, safety of oral dexpramipexole in subjects with moderate to severe or severe eosinophilic asthma. These are global studies taking place in the UK where patients will be recruited mostly from primary care. We wish to gather feedback from a patient cohort who could be eligible to take part in the study. We wish to acquire patient insights into the informed consent form (ICF), study design including visit schedule and study process especially online booking for the initial study visit. This feedback will be reviewed and incorporated, where possible, into the submission for Combined Review. We will also use the results to inform the development of future studies as part of this programme. It is expected that the results will improve the accessibility of the ICF and other patient facing materials and processes. It is also hoped that insights can be used to support patient centered design of trials across our programme in line with FDA, MHRA and NHS guidance.

15/09/2022

TRE