The RECOVER study

Details

CTAP badge
Therapeutic approach
Observational
Trial status
Open to recruitment Participating Centres
Trials Tracker ID
TT007011
Last updated
15/02/2022

Full title

A study investigating the impact of Kaftrio® on key clinical outcomes in people with CF in a real-world setting

Study 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.


Phase
Not applicable
Length of participation
27 months
Recruitment target
62
CF sponsor
Royal College of Surgeons in Ireland
CF sponsor type
Academic

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.

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CF centres running this trial

Recruiting

Belfast

CTAP centre
NHS Trust
Belfast Health & Social Care Trust
Local site investigator
Alastair Reid
Recruiting

Royal Brompton Hospital (London)

CTAP centre
NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Address
Royal Brompton Hospital
Sydney Street
SW3 6NP
Local site investigator
Jane Davies