Study Updates
Study Milestones
10th September 2020 – RECOVER’s first patient recruited at University Hospital Limerick
118 adolescents and adults have been recruited to the 12+ cohort since 2020
November 2021 – Recover data on display at NACFC
632 Sweat Chloride assessments have been performed on RECOVER since 2020
762 LCIs have been performed on RECOVER since 2020
263 Spirometry controlled CT assessments have been preformed on RECOVER since 2020
January 2021, RECOVER was recognised as a clinical trial by the UK regulatory body, the MHRA
New collaborations with Amsterdam University medical Centre and CAMI in St. James
In Q4 2021, Psychology and Sinus disease sub-studies began recruiting patients
January 2022, Kaftrio license extended to patients aged 6-11 years old and recruitment across all paediatric sites begins
Q4 2022, 2nd Psychology sub-study begins recruiting participants
November 2022 – RECOVER Data on Display at NACFC
March 2023 – Kaftrio license extends to 6-11 with heterozygous deltaF508/minimal function mutations
June 2023 – First in-person RECOVER meeting with collaborators, participants and families
June 2023 – RECOVER Data on Display at ECFS
July 2023 – Total participant numbers reach 206
July 2023 – RECOVER extension study announced
Nov 2023 – RECOVER Data on Display at NACFC
December 2023: Consenting to five year RECOVER Extension study begins
December 2023: First 3-year visit as part of the extension takes place
By January 2024, 37 participants recruited to sinus and nasal substudy
Results from sinus and nasal substudy showed that imaging severity improved, while symptoms and nasal swab culture showed no significant change
Since 2020, RECOVER has seen 206 patients recruited to RECOVER across both UK and Irish sites. Navigating COVID restrictions, the RECOVER team successfully conducted visits across all sites utilising a mix of virtual and in-person 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 all sites are now activated all sites recruited and both cohorts are closed for recruitment. All participants in the 12 years and older group have completed the 24-month visit. Meanwhile, those within the 6-11 year old cohort are estimated completed within the next 6.
Our dedicated team have conducted over 1824 visits so far, with data being shared with our International Collaborators with an aim to observe the impact Kaftrio is having on the adult and adolescent cohort. As testament to the work 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 2023, as well as at the North American Cystic Fibrosis Conference 2023. A paper on lung improvement was published in the American Journal of Respiratory and Critical Care Medicine. Please go to our publications section to read this.
Kervin Soobrayan, pursuing a Masters in Psychology at University College Dublin and supervised by Dr Niki Nearchou, leads the psychology segment of the RECOVER study, with research that aims to unveil valuable insights into the understanding of heterozygous patients regarding their condition and treatment. This involves a select group of participants aged 6-11 years old receiving invitations to engage in a brief interview, incorporating open-ended questions and drawings. Throughout the interview, participants will be asked about their knowledge of CF, identifying factors that assist or impede them, and expressing how CF influences their emotions. It’s important to emphasize that participants’ responses will not be corrected by the researcher, and no additional information about CF will be introduced during the interview.
A total of 37 children were recruited to the sinus and nasal disease sub-study. Questionnaires, MRI scans and nasal swabs were collected from participants prior to and following 6 months of triple combination modulator therapy. An overall improvement in imaging severity was observed with no significant change observed in symptom burden or nasal swab culture results. Further work is currently underway using shotgun metagenomic sequencing to evaluate for changes in the sinonasal microbiome.
The RECOVER team is in the process of seeking approval from the ethics committees for a 5-year extension to the study. This extension involves an annual visit for each patient, encompassing activities such as the collection of a sweat test, LCI function, stool sample, serum sample, mental health-related questionnaires, 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 give us longitudinal data on the effects of Kaftrio.
The achievements to date, outlined in our study milestones, could not have been met without the fantastic RECOVER participants, our PPI team, our collaborators and our research teams. For this, we would like to extend our 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.