Inhaled hypertonic saline improves structural airway changes in children with cystic fibrosis

Inhaled hypertonic saline treatment for 48 weeks led to positive effects on structural lung changes in young children with cystic fibrosis compared with isotonic saline, researchers reported in The Lancet Respiratory Medicine.

Harm A.W.M. Tiddens, MD, professor in the department of pediatrics/respiratory medicine at Sophia Children’s Hospital in Rotterdam, the Netherlands, and colleagues conducted the SHIP-CT trial to evaluate the effects of inhaled hypertonic saline on chest CT imaging in young children with cystic fibrosis. In the prior SHIP study, inhaled hypertonic saline improved the lung clearance index in children, but effects on structural lung disease remained unclear.

The randomized, double-blind, controlled, parallel-group SHIP-CT trial included 116 children aged 3 to 6 years with cystic fibrosis from 23 cystic fibrosis centers in Spain, Denmark, the Netherlands, Italy, France, Belgium, the U.S., Canada and Australia from May 2016 to December 2019. All children were randomly assigned to receive inhaled two puffs of 100 µg salbutamol followed by 4 mL of 7% hypertonic saline (n = 56) or 0.9% isotonic saline (n = 60) twice daily for 48 weeks. Researchers collected chest CT scans at baseline and 48 weeks.

The primary outcome was the difference between the two groups in the percentage of total lung volume occupied by abnormal airways at 48 weeks.

During the study period, seven children in the hypertonic saline group and five in the isotonic saline group dropped out. Among the remaining children, mean percentage of total lung volume occupied by abnormal airways at 48 weeks was 0.88% among those in the inhaled hypertonic saline group and 1.55% among children in the isotonic saline group (P = .0092).

Adverse events occurred in 563 children in the inhaled hypertonic saline group and 622 in the isotonic saline group. Most adverse events were mild. The most commonly reported adverse events were cough, nasal congestion, fever and rhinorrhea in both groups.

“We recommend that inhaled hypertonic saline be considered for all young children, particularly those without access to [cystic fibrosis transmembrane conductance regulator] modulatory therapy, to minimize progression of structural lung damage,” the researchers wrote. “For clinical trials for therapies to treat cystic fibrosis lung disease in children younger than 6 years, we recommend including outcome measures to evaluate both lung structure and function.”