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.

Timeline

Start

2020-09-03

Primary completion

2029-04-01

Completion

2029-07-01

Outcome

Met primary endpoint

paper Significant improvements were seen in LCI scores (-2.5; 95% confidence interval [CI], -3.0, -2.0) PMID 37703083 ↗

paper Significant improvements were seen in LCI scores (-2.5; 95% confidence interval [CI], -3.0, -2.0) and in the percents predicted for FEV1 (8.9; 95% CI, 7.0, 10.9). PMID 37703083 ↗

Publications

• McNally P, Lester K, Stone G, Elnazir B, Williamson M, Cox D, Linnane B, Kirwan L, Rea D, O'Regan P, Semple T, Saunders C, Tiddens HAWM, McKone E, Davies JC; RECOVER Study Group. Improvement in Lung Clearance Index and Chest Computed Tomography Scores with Elexacaftor/Tezacaftor/Ivacaftor Treatment in People with Cystic Fibrosis Aged 12 Years and Older - The RECOVER Trial. Am J Respir Crit Care Med. 2023 Nov 1;208(9):917-929. doi: 10.1164/rccm.202308-1317OC.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Kaftrio	Unknown	—	—

Indications