CompletedNot Applicable

CFTR Modulators and Gastrointestinal Complications

United Kingdom47,023 participantsStarted 2021-10-01

Plain-language summary

To elucidate the similarities and distinctions in non-pulmonary manifestations of cystic fibrosis (CF) including distal intestinal obstruction syndrome (DIOS) incidence and pancreatic enzyme replacement therapy (PERT) use between US and UK CF populations in a parallel study using data from the UK and US CF registries. To assess how CFTR modulators impacted upon recorded PERT use and incidence of DIOS.

Who can participate

SexALL

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Inclusion Criteria: * All patients with CF of any genotype on the UK and US cystic fibrosis registries from the period 2007 - 2018. Exclusion Criteria: \- Patients whose CFTR modulator status is unknown or only have one year of CFTR data recorded on the registry will be excluded from the analysis of the effects of CFTR modulators. This is to account for the fact that DIOS data is annualised on the registries, therefore there is no certainty at what time of year DIOS was diagnosed in relation to commencing CFTR modulator therapy.

What they're measuring

Describe DIOS events and PERT usage in UK and US registries 2007-2018

Timeframe: 2 years

Determine the effect of CFTR modulators on the incidence of DIOS and use of PERT: population level controlled interrupted time series (ITS)

Timeframe: 2 years

Determine the effect of CFTR modulators on the incidence of DIOS and use of PERT: patient-level time series

Timeframe: 2 years

Trial details

NCT IDNCT05253859

SponsorNottingham University Hospitals NHS Trust

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-02-10

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