Abstract
Objectives: SIMPLIFY tested withdrawal of hypertonic saline (HS) or dornase alfa for 6 weeks in PwCF taking ETI and showed non-inferiority (compared with continuing HS or dornase alfa) in both lung function and respiratory symptom scores. Inclusion in either trial required ppFEV1 ≥60%, and the mean ppFEV1 was 97%. A pre-planned lower lung function (LLF) sub-study was conducted to test HS withdrawal in PwCF with ppFEV1 of 40–59%, hypothesizing that continuing HS is superior to discontinuing HS with respect to 6-week change in ppFEV1. Dornase alfa was not tested in the LLF sub-study.
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