Inhaled hypertonic saline in preschool children with cystic fibrosis (SHIP): A multicentre, randomised, double-blind, placebo-controlled trial
The Lancet Respiratory Medicine Sep 10, 2019
Ratjen F, Davis SD, Stanojevic S, et al. - In a randomised, double-blind, placebo-controlled trial, the Saline Hypertonic in Preschoolers Study, researchers determined how the lung clearance index (LCI 2·5)—a measure of ventilation inhomogeneity—was influenced by inhaled hypertonic saline in children aged 3–6 years with cystic fibrosis. This investigation was run at 25 cystic fibrosis centres in Canada and the USA. They randomly allocated (1:1) participants to inhaled 7% hypertonic saline or 0·9% isotonic saline nebulised twice daily (for no more than 15 min per dose) for 48 weeks. From baseline to week 48, the change in the LCI 2·5 measured by nitrogen multiple breath washout was considered as the primary endpoint. In children aged 3–6 years, improvement in the LCI 2·5 was observed as a result of treatment with inhaled hypertonic saline. Cough (two patients [3%] in the hypertonic saline group vs three [4%] in the isotonic saline group), gastrostomy tube placement or rupture (two [3%] vs one [1%]), upper gastrointestinal disorders (one [1%] vs two [3%]), distal intestinal obstruction syndrome (one [1%] vs one [1%]), and reduced pulmonary function (none vs one [1%]) were documented as the serious adverse events that occurred. None of these was treatment-related. Overall, inhaled hypertonic saline could afford a suitable early intervention in cystic fibrosis.
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