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Inhaled hypertonic saline has outperformed inhaled isotonic saline in reducing the incidence of pulmonary exacerbations in adults and older children who have cystic fibrosis (CF). Now, researchers have randomized 321 young children with CF (age range, 4–60 months) to receive either 7% hypertonic saline or 0.9% isotonic saline, inhaled twice daily after a dose of albuterol or levalbuterol, for 48 weeks.
The incidence of pulmonary exacerbations (defined as treatment for pulmonary signs or symptoms with an inhaled or intravenous antibiotic) was 2.3 events per person-year in both groups. During the documented pulmonary exacerbations, neither the number of antibiotics used nor the duration of their use differed significantly between the hypertonic and isotonic groups. Outcomes for the two treatment groups were also similar among the 73 children who participated in a pulmonary-function substudy. The trial raised no noteworthy safety concerns.
Rosenfeld M et al. Inhaled hypertonic saline in infants and children younger than 6 years with cystic fibrosis: The ISIS randomized controlled trial. JAMA 2012 May 20; [e-pub ahead of print]. (http://dx.doi.org/10.1001/jama.2012.5214)
Dasenbrook EC and Konstan MW. Inhaled hypertonic saline in infants and young children with cystic fibrosis. JAMA 2012 May 20; [e-pub ahead of print]. (http://dx.doi.org/10.1001/jama.2012.5853)
Comment
Given these trial findings, the routine use of hypertonic saline to prevent pulmonary exacerbations in young children with cystic fibrosis is not warranted. The study did not evaluate long-term progression of CF-related lung disease.