RECOVER, led by Professor Paul McNally, is a large, multi-center study which is taking place in eight paediatric and adult sites across Ireland and the UK. Initially RECOVER was due to take place over a three-year period but given the success of the study, the team have applied for a five-year extension. Funded by CF Ireland, the CF Foundation (US) and the CF Trust (UK), the study is examining in detail the impact of the new triple combination CFTR modulator compound, Elexacaftor/Tezacaftor/Ivacaftor (ETI), on the lives and health of people with CF. RECOVER is not a clinical trial as it is examining the effects of ETI only after it has been prescribed for patients by their medical team.
The project gathers both routine health data and less commonly used clinical endpoints such as lung clearance index, Chest CT, gastrointestinal symptoms, inflammation and medication adherence, providing unique insights into the effects of the triple combination drug. The project is run in conjunction with the CF registry of Ireland and the UK CF registry. Since 2020, RECOVER has seen 206 patients recruited across Ireland and the UK. Navigating COVID restrictions, the RECOVER team successfully recruited to the study and carried out baseline study visits. In January 2021, the study was recognised as a clinical trial in the UK sites which led to delays in site activity for our colleagues at Belfast Health and Social Care Trust.
Through hard work and determination, sites recruited to target and both cohorts are now closed for recruitment. All participants in the 12 years and older group have completed the 24-month visit, with those in the 6-11 year old cohort due to complete the 24-month visits by the end 2024. The dedicated team have conducted over 1800 visits so far, with data being shared with the International Collaborators with an aim to observe the impact Elexacaftor/Tezacaftor/Ivacaftor (ETI) is having on the adult and adolescent cohort. As testament to the work done by the RECOVER team, data derived from the study has been on display at international conferences. In 2023, findings from the study were presented at two conferences , the European Cystic Fibrosis Society Conference (ECFS), as well as at the North American Cystic Fibrosis Conference (NACFC). A paper on lung improvement was published in the American Journal of Respiratory and Critical Care Medicine and a paper on Reduction in abdominal symptoms was published in The Journal of Cystic Fibrosis. As mentioned, the RECOVER team are in the process of seeking approval from all sites for a 5-year extension to the study. This extension involves an annual visit, encompassing activities such as the collection of a sweat test, LCI function, stool sample, serum sample, abdominal questionnaires, and the CFQR.
Additionally, individuals in the advanced cohort will undergo the collection of a nasal lavage, sputum sample and spirometry controlled CT. This additional five year study will provide longitudinal data on the effects of Elexacaftor/Tezacaftor/Ivacaftor (ETI). The extension also includes mental health questionnaires. The additional aim for the extension study will improve our knowledge within multiple mental health areas of focus and areas of encouragement for CF clinical research. The achievements to date could not have been met without the fantastic RECOVER participants, our PPI team, our collaborators and our research teams. For this, the Recover team would like to extend their sincere gratitude to everyone who has been involved up to this point and we look forward to continued success as we navigate through the coming year.
If you would like to know more about the RECOVER study and to see the posters that were presented at ECFS and NACFC, please visit www.realworld4cf.com/recover