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

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.

Conditions

• Cystic Fibrosis
• Cystic Fibrosis Liver Disease
• Cystic Fibrosis in Children
• Adherence, Medication
• Cystic Fibrosis Gastrointestinal Disease

Interventions

DRUG

Kaftrio

The intervention is the same for both study groups. In addition to all the assessments in the standard arm, the advanced arm subjects will undergo spirometry controlled CT, nasal lavage and sputum sample collection.

Sponsors & Collaborators

• Imperial College London

  collaborator OTHER

• University College Dublin

  collaborator OTHER

• University of Limerick

  collaborator OTHER

• Cystic Fibrosis Registry of Ireland

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Medizinische Hochschule Brandenburg Theodor Fontane

  collaborator OTHER

• Queen's University, Belfast

  collaborator OTHER

• Teagasc

  collaborator INDUSTRY

• The Hospital for Sick Children

  collaborator OTHER

• St. James's Hospital, Ireland

  collaborator OTHER

• Amsterdam UMC

  collaborator OTHER

• Royal College of Surgeons, Ireland

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-03

Primary Completion

2029-04-01

Completion

2029-07-01

Countries

• Ireland
• United Kingdom

Study Locations