TY - JOUR T1 - RCT Abstract - The effect of inhaled hypertonic saline on lung structure in preschool children with cystic fibrosis JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.congress-2021.PA3382 VL - 58 IS - suppl 65 SP - PA3382 AU - Harm Tiddens AU - Yuxin Chen AU - Eleni-Rosalina Andrinopoulou AU - Stephani D. Davis AU - Margaret Rosenfeld AU - Felix Ratjen AU - Richard A. Kronmal AU - Karen D. Stukovsky AU - Stephen Stick Y1 - 2021/09/05 UR - http://erj.ersjournals.com/content/58/suppl_65/PA3382.abstract N2 - Background: Inhaled 7% hypertonic saline(HS) is used to improve mucociliary clearance for Cystic Fibrosis (CF) lung disease. It is unclear if HS maintenance therapy can slow progression of CF structural lung changes in preschool children with CF (pCwCF).Objective: To investigate the efficacy of inhaled HS for 48 weeks on quantitative chest CT score in pCwCFMethods: pCwCF aged 3-6 years were enrolled in a multicentre, randomised, double-blind, controlled trial. pCwCF were randomised to 7% HS or 0.9% isotonic saline(IS) inhalation twice daily for 48 weeks. CTs were obtained at baseline and 48 weeks and were scored using PRAGMA-CF method to quantify % of lung volume occupied by Bronchiectasis (%BE), Mucus Plugging (%MP) and Airway Wall Thickening (%AWT) on inspiratory scans and Trapped Air(%TA) on expiratory scans. Primary outcome was %Dis which is the sum of airway-related abnormalities (%BE+%MP+%AWT). Regression analysis was used to investigate the difference in %Dis at 48 weeks between groups.Results: 116 pCwCF (56 HS, 60 IS), median age 55.0 months (range 36.2-71.7 months) were enrolled at 23 sites in Europe, North America, and Australia. Mean(95%CI) estimated %Dis at 48 weeks was 0.93 (0.63,1.23) in the HS and 1.60(1.31,1.88) in the IS(mean difference 0.67,95%CI, 0.25 to 1.09; p=0.019). Similar differences between groups were found in %BE and %TA (p=0.016 and p=0.005, respectively).Conclusion: Inhaled HS for 48 weeks had a significant positive and clinically relevant impact on structural lung changes on chest CT in pCwCF relative to IS. This is the first demonstration of an intervention that alters the progressive trajectory of structural disease in young children with CF (Funded by CFFT).FootnotesCite this article as: European Respiratory Journal 2021; 58: Suppl. 65, PA3382.This abstract was presented at the 2021 ERS International Congress, in session “Prediction of exacerbations in patients with COPD”.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only). ER -