Study design (if review, criteria of inclusion for studies)
randomized, double-blind, controlled trial
42 infants with CF less than 4 months of age
Inhalation with hypertonic saline (HS) compared to isotonic saline (IS) patients were randomized across 5 sites to twice daily inhalation of 6% HS (n=21) or 0.9% IS (n=21) for 52 weeks.
LCI, MRI, adverse events, weight gain, pulmonary exacerbations.
Inhalation of HS and IS was generally well tolerated by CF infants and the number of adverse events did not differ between groups (P=0.49). The change in LCI from baseline to week 52 was larger in CF infants treated with HS (-0.6) compared to IS (-0.1, P<0.05). In addition, weight gain was improved in CF infants treated with HS (P<0.05), whereas pulmonary exacerbations and chest MRI scores did not differ in the HS vs. IS group.
Preventive inhalation with HS initiated in the first months of life was safe and well tolerated, and resulted in improvements in LCI and weight gain in infants with CF. Our results support feasibility of LCI as endpoint in randomized controlled trials in infants with CF.