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. 2024 Feb;21(2):360-362.
doi: 10.1513/AnnalsATS.202308-735RL.

Assessing Safety of Discontinuing Hypertonic Saline in Those with Lower Forced Expiratory Volume in 1 Second after Elexacaftor/Tezacaftor/Ivacaftor

David Nichols  1 , Alex Gifford  2 , Renee Russell  3 , Katherine Odem-Davis  3 , Julia Young  3 , Rodolfo Amaro-Galvez  4 , Joanne Billings  5 , Zubin Mukadam  6 , Nicole Mayer-Hamblett  1   7
Affiliations

Assessing Safety of Discontinuing Hypertonic Saline in Those with Lower Forced Expiratory Volume in 1 Second after Elexacaftor/Tezacaftor/Ivacaftor

David Nichols et al. Ann Am Thorac Soc. 2024 Feb.
No abstract available

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Figures

Figure 1.
Figure 1.
Mean absolute changes from Week 0 and estimated 6-week treatment differences for percent-predicted forced expiratory volume in 1 second (ppFEV1), the Chronic Respiratory Infection Symptom Score (CRISS), and the Cystic Fibrosis Questionnaire-Revised Respiratory domain (CFQ-R Resp.). Points are within-arm unadjusted mean changes from Week 0 at each time point along the x-axis. Bars indicate t-distribution 95% confidence intervals. Numbers of participants with an observation at each week, in each arm, are listed below the x-axis. The estimated 6-week treatment difference between arms (Discontinue − Continue), with 95% confidence interval in parentheses, is printed with a bracket at Week 6. For reference, the ppFEV1 noninferiority margin used in the main SIMPLIFY trial was −3% for the absolute difference between groups. For CRISS, a previously suggested minimally important difference was 11 (7). For CFQ-R Resp., a previously established minimal clinically important difference is −4 (8). HS = hypertonic saline.
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References

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    1. Mayer-Hamblett N, Nichols DP, Odem-Davis K, Riekert KA, Sawicki GS, Donaldson SH, et al. Evaluating the impact of stopping chronic therapies after modulator drug therapy in cystic fibrosis: the SIMPLIFY clinical trial study design. Ann Am Thorac Soc . 2021;18:1397–1405. - PMC - PubMed
    1. Mayer-Hamblett N, Ratjen F, Russell R, Donaldson SH, Riekert KA, Sawicki GS, et al. SIMPLIFY Study Group Discontinuation versus continuation of hypertonic saline or dornase alfa in modulator treated people with cystic fibrosis (SIMPLIFY): results from two parallel, multicentre, open-label, randomised, controlled, non-inferiority trials. Lancet Respir Med . 2023;11:329–340. - PMC - PubMed
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