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

RECOVER is a prospective, multicenter observational study designed to measure the real world clinical effectiveness of elexacaftor, tezacaftor and ivacaftor triple combination therapy (Kaftrio) in people with cystic fibrosis over a two year 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 children aged six years and above over a period of two years. The first phase of the study will commence in 2020, recruiting children 12 years and older who have started on clinical treatment with Kaftrio.

NCT Number	NCT04602468
Lead Sponsor	Royal College of Surgeons, Ireland Collaborators: Imperial College London, University College Dublin, University of Limerick, Cystic Fibrosis Registry of Ireland, Erasmus Medical Center, Medizinische Hochschule Brandenburg Theodor Fontane, Queen's University, Belfast, Teagasc, The Hospital for Sick Children, St. James's Hospital, Ireland, Amsterdam UMC
Conditions	Cystic Fibrosis, Cystic Fibrosis Liver Disease, Cystic Fibrosis in Children, Adherence, Medication, Cystic Fibrosis Gastrointestinal Disease
Enrollment	237 participants
Start Date	2020-09-03
Primary Completion	2029-04-01 (estimated)
Study Completion	2029-07-01 (estimated)
Updated on ClinicalTrials.gov	2024-05-02