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Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER)
Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER)

NCT04602468

Active Not RecruitingPhase 4

Sponsor: Royal College of Surgeons, Ireland

Conditions: Cystic Fibrosis, Cystic Fibrosis Liver Disease, Cystic Fibrosis in Children, Adherence, Medication, Cystic Fibrosis Gastrointestinal Disease

Interventions: Elexacaftor/Tezacaftor/Ivacaftor

Countries: Ireland, United Kingdom

RECOVER is a prospective, multicenter observational study designed to measure the real world clinical effectiveness of elexacaftor/tezacaftor/ivacaftor (ETI) triple combination therapy in people with cystic fibrosis initially over a two year period, followed by a five year extension period. Measured outcomes include measures of lung function, lung inflammation, lung imaging, abdominal symptoms, gut inflammation, liver function, pancreatic exocrine function, nasal inflammation, quality of life and adherence to therapy. The study will examine outcomes in two cohorts, children aged six to eleven years and children and adults aged twelve and above.

Eligibility overview

Sex: ALL

Age: 6 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

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 ETI in compliance with the official marketing authorization and summary of product characteristics (SPC).

The decision to include participants in the study is independent of decision to prescribe ETI.

Participants will receive treatment only through prescription by their physician through usual clinical treatment pathways.

Subjects on ETI In exceptional circumstances where baseline clinical data has been collected prior to the start of treatment either through clinical care or ethically approved research projects (including a cohort of subjects initially recruited to this study on the understanding that it was a non-regulated observational study) subjects already receiving ETI may be recruited to this study and undergo on-treatment visits. Any additional patient data can only be added with written informed consent from the patients/parents concerned.

All subjects must have a signed informed consent form and/or signed assent form when appropriate, as determined by the subjects age and individual site and country standards.

Male and female participants of childbearing potential must agree to adhere to contraception requirements as detailed in the local ETI SmPC and in line with the standard of care.

Exclusion Criteria:

Patients not willing to comply with study procedures or assessments.

Individuals on clinical trials of investigational CFTR modulators.

Clinical instability at baseline assessments. Subjects undergoing an active exacerbation and at the beginning of their treatment should be excluded from the study as this is likely to skew the data.
Locations (7)
  • Dublin, Leinster, Ireland
  • Limerick, Limerick, Ireland
  • Dublin, Ireland
  • Dublin, Ireland
  • Tallaght, Ireland
  • Belfast, United Kingdom
  • London, United Kingdom