Inhaled Hypertonic Saline vs Isotonic Saline for Children With Cystic Fibrosis

Compared with isotonic saline, use of inhaled hypertonic saline during a period of 48 weeks resulted in beneficial lung changes in children with cystic fibrosis aged 3 to 6 years. These and other research findings were recently published in the Lancet.

Previously, in the Saline Hypertonic in Preschoolers (SHIP) study (ClinicalTrials.gov Identifier: NCT02378467), investigators found that inhaled 7% hypertonic saline enhanced the lung clearance index in children aged 3 to 6 years with cystic fibrosis. It remained to be elucidated, however, whether improvement occurred in structural lung disease. In the current study, investigators analyzed the impact of inhaled hypertonic saline on chest computed tomography (CT) imaging in children aged between 3 and 6 years with cystic fibrosis.

In the current study, Saline Hypertonic in Preschoolers + CT (SHIP-CT; ClinicalTrials.gov Identifier: NCT02950883) total, researchers recruited 116 participants who were randomized 1:1 to hypertonic saline or isotonic saline, with 12 patients dropping out. Chest CTs, obtained at baseline and 48 weeks, were scored using the Perth-Rotterdam Annotated Grid Morphometric Analysis for Cystic Fibrosis (PRAGMA-CF) method; the primary outcome was the difference between groups in the percentage of total lung volume occupied by abnormal airways (PRAGMA-CF %Disease) at 48 weeks.

Researchers found that the mean PRAGMA-CF %Disease at 48 weeks was 0.88% in the hypertonic saline group vs 1.55% in the isotonic saline group, with an average difference of 0.67% (P =.0092). Adverse events were mostly mild, with cough being the most common complaint.

“We showed that treatment with inhaled hypertonic saline for 48 weeks resulted in less structural lung damage compared with children in the isotonic group,” wrote the authors. “In addition, SHIP-CT combined CT outcomes and lung clearance index to improve our understanding of the relationship between structural and functional outcomes in this younger age group,” they further noted.

Limitations of the current study include the comparator isotonic saline impairing mucociliary clearance. Another limitation is that the use of chest CT exposed the participants to radiation.

The authors concluded that the SHIP-CT study demonstrated hypertonic saline is a safe, inexpensive, and effective intervention to decrease structural lung damage in cystic fibrosis patients aged 3 to 6 years. The authors recommend that inhaled hypertonic saline be an option in children — especially those lacking access to cystic fibrosis transmembrane regulator modulator therapy. This option will limit the progression of structural lung disease.

Disclosure: This research was supported by Cystic Fibrosis Foundation Therapeutics. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Tiddens HAWM, Chen Y, Andrinopoulou ER, et al; SHIP-CT Study Group. The effect of inhaled hypertonic saline on lung structure in children aged 3-6 years with cystic fibrosis (SHIP-CT): a multicentre, randomised, double-blind, controlled trial. Lancet Respir Med. Published online March 11, 2022. doi: 10.1016/S2213-2600(21)00546-4