The CF STORM Trial

Details

Therapeutic category
Other
Trial status
Project in Setup Participating Centres

Full title

CF STORM; A trial to assess change in respiratory function for people with cystic fibrosis on triple combination therapy (Kaftrio™) after rationalisation of nebulised mucoactive therapies

For people with cystic fibrosis (pwCF), how to reduce treatment burden has been identified as the top priority research question. Daily nebulised treatments were identified by pwCF as burdensome. The CF STORM trial will recruit pwCF age 12 years and above that have been established on Kaftrio™ therapy. They will have an equal chance of being allocated to either stop or continue their daily nebulised muco-active therapies (dornase alfa, hypertonic saline or both). The trial is designed to provide confidence that stopping these nebulisers does not result in a significant decline in lung function over 12 months. The trial will not involve extra visits outside of normal clinical care.
Trial Reference Number
138613
Trial type
Non-medication
Recruitment target
764
Last edited date
04/03/2021
CF sponsor
Alder Hey - Liverpool
CF sponsor type
Academic

Who can take part?

Age
12+
Top inclusion criteria
  • 1) Established on Kaftrio™ therapy for more than 3 months
  • 2) FEV1 > 40 percent predicted
  • 3) Established on daily muco-active therapies (dornase alfa (Pulmozyme™), hypertonic saline or both) for more than 3 months
  • 4) 12 year and older

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