Active — Not RecruitingPhase 4

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

Ireland237 participantsStarted 2020-09-03

Plain-language summary

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.

Who can participate

Age range6 Years

SexALL

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Inclusion Criteria: Inclusion criteria People with CF aged 12 years and over: 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 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 Kaftrio. Participants will receive treatment only through prescription by their physician through usual clinical treatment pathways. Children aged 6-11 years: Children aged 6-11 years will be included in the study only if and when Kaftrio is licenced, approved and funded for this age group. 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 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 Kaftrio. Participants will receive treatment only through prescription by their physician through usual clinical treatment pathways. Subjects on Kaftrio 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…

What they're measuring

To determine the effect of treatment with TCMT on pulmonary function (FEV1 and LCI) in children and adults with CF over a period of 2 years.

Timeframe: 24 month period

Trial details

NCT IDNCT04602468

SponsorRoyal College of Surgeons, Ireland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-04-01