Hypertonic saline may be appropriate intervention for preschoolers with cystic fibrosis
New data from the SHIP study show that inhaled hypertonic saline, as compared with isotonic saline, improved lung clearance index in children aged 3 to 6 years with cystic fibrosis.
Specifically, at 48 weeks, children randomly assigned hypertonic saline experienced a significant decrease in lung clearance index (LCI2.5) when compared with children assigned isotonic saline, with a mean treatment effect of –0.63 LCI2.5 units (95% CI, –1.1 to –0.15). Results were similar in sensitivity analyses, the researchers reported.
Also at 48 weeks, Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain scores declined in both the hypertonic saline and isotonic saline groups, with no significant unadjusted (0.1 points; 95% CI, –5.7 to 5.8) or adjusted treatment differences (0.1; 95% CI, –5.3 to 5.4) between groups. However, LCI2.5 did not correlate significantly with CFQ-R scores in either treatment group.
Additionally, neither change in FEV0.75 from baseline nor time to first pulmonary exacerbation was significantly different between the hypertonic saline and isotonic saline (HR = 0.94; 95% CI, 0.65-1.36).
Adverse events occurred at a similar rate in both treatment groups, with most classified as mild. Six patients in the hypertonic saline group experienced 10 serious adverse events and eight in the isotonic saline group had nine serious adverse events. These events included cough (3% in the hypertonic saline group vs. 4% in the isotonic saline group), gastrostomy tube placement or rupture (3% vs. 1%, respectively), upper gastrointestinal disorders (1% vs. 3%, respectively), distal intestinal obstruction syndrome (1% vs. 1%, respectively) and decreased pulmonary function (0% vs. 1%, respectively) — none of which were considered related to treatment.
“In conclusion, our data therefore support the use of hypertonic saline as an early intervention strategy in children aged 3 [to] 6 years with cystic fibrosis,” the researchers wrote. “However, because the minimal clinically important difference for the LCI2.5 has not been established, and the magnitude of the treatment effect was small, we would recommend that clinicians enter into shared decision-making with families, helping them to weigh the treatment effect and the possibility of slowing disease progression against the lack of effect on symptoms and the treatment burden of inhaled therapy.”
In the double-blind, placebo-controlled SHIP trial, the researchers randomly assigned 150 patients aged 3 to 6 years with cystic fibrosis to 4 mL 7% hypertonic saline (n = 76) or 0.9% isotonic saline (n = 74) twice daily by inhalation at 25 cystic fibrosis centers in the United States and Canada from 2015 to 2017. Change in LCI2.5 — the primary endpoint — was measured by multiple breath washout. – by Melissa Foster