Inhaled hypertonic saline in infants and children younger than 6 years with cystic fibrosis: the ISIS randomized

Margaret Rosenfeld1, Felix Ratjen, Lyndia Brumback

  • 1Division of Pulmonary Medicine, Seattle Children's Hospital, Seattle, Washington 98105, USA. margaret.rosenfeld@seattlechildrens.org

JAMA
|May 22, 2012
PubMed

Insights

Inhaled hypertonic saline did not reduce pulmonary exacerbations in young children with cystic fibrosis (CF). This study found no significant difference in exacerbation rates between hypertonic saline and isotonic saline treatments.

Area of Science:

  • Pediatric Pulmonology
  • Respiratory Medicine
  • Clinical Trials

Background:

  • Inhaled hypertonic saline is a recommended therapy for cystic fibrosis (CF) patients aged 6 years and older.
  • The efficacy of inhaled hypertonic saline in CF patients younger than 6 years has not been previously evaluated.

Purpose of the Study:

  • To determine if inhaled hypertonic saline reduces the rate of pulmonary exacerbations in CF patients younger than 6 years.
  • To assess the safety and efficacy of hypertonic saline in this pediatric population.

Main Methods:

  • A multicenter, randomized, double-blind, placebo-controlled trial (Infant Study of Inhaled Saline in Cystic Fibrosis - ISIS) was conducted.
  • 321 participants aged 4 to 60 months with CF received either 7% hypertonic saline or 0.9% isotonic saline twice daily for 48 weeks.
  • The primary outcome was the rate of protocol-defined pulmonary exacerbations requiring antibiotic treatment.

Main Results:

  • The mean pulmonary exacerbation rate was 2.3 events per person-year in both the hypertonic saline and isotonic saline groups (adjusted rate ratio 0.98; 95% CI, 0.84-1.15).
  • No significant differences were observed in secondary endpoints, including growth, respiratory symptoms, or lung function (exploratory outcome).
  • Adverse event profiles were similar between groups, with cough being the most common moderate/severe event.

Conclusions:

  • Inhaled hypertonic saline, compared to isotonic saline, did not reduce the rate of pulmonary exacerbations in infants and children younger than 6 years with CF over 48 weeks.
  • The findings suggest that current recommendations for hypertonic saline therapy in CF may not extend to children under 6 years of age.
Abstract

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