The RECOVER study
- Therapeutic approach
- Trial status
- Open to recruitment Participating Centres
- Trials Tracker ID
- Last updated
A study investigating the impact of Kaftrio® on key clinical outcomes in people with CF in a real-world settingStudy details
The aim of RECOVER is to examine the impact of Kaftrio® on key clinical outcomes in people with CF in a real-world setting.
This clinical trial will use traditional methods of monitoring clinical outcomes in people with CF (e.g. standard lung function, nutrition, exacerbations and liver disease), as well as some new outcome measures not typically used in clinical trials such as lung clearance index (LCI) and spirometry controlled chest CT. These new measures may provide more detail of how taking Kaftrio® affects the lungs.
This study will look at many important outcomes in a number of areas of health in people with CF. Participation will be for 27 months and visits will involve a number of evaluations including measures of lung function, sweat chloride, liver disease assessment, abdominal symptom and quality-of-life questionnaires.
The study will also involve collection of clinical samples (sputum, nasal lavage, stool) to look at inflammation and microbiology of the airways and gut as well as assessing pancreatic function. From this, the RECOVER study will be able to shed more light on how Kaftrio® works, and what impact it has on rescuing and restoring CFTR function in this group of people.
- Not applicable
- Length of participation
- 27 months
- Recruitment target
- CF sponsor
- Royal College of Surgeons in Ireland
- CF sponsor type
Who can take part?
- Age range
- 6 years and older
- Including people
Participants may only be selected for inclusion in RECOVER if they have been independently determined by their treating physician to be suitable for treatment with Kaftrio®.
All subjects (peole with CF aged 12 years and over, children aged 6-11 years and subjects on Kaftrio®) must be taking the full, age-appropriate dose of Kaftrio®.
- Excluding people
Pregnant and breastfeeding women.
Individuals on clinical trials of investigational CFTR modulators.
Clinical instability at baseline assessments, e.g. subjects undergoing an active exacerbation and at the beginning of their treatment.
Get in touch