Inhaled hypertonic saline no help for young children with cystic fibrosis
MedWire News: Cystic fibrosis (CF) patients younger than 6 years of age do not benefit from inhalation of hypertonic saline, show study findings.
"Hypertonic saline has been demonstrated to increase airway surface liquid in bronchial epithelial cells in vitro and to improve defective mucociliary clearance in patients with CF," explain Margaret Rosenfeld (University of Washington School of Medicine, Seattle, USA) and colleagues in JAMA.
Previous research demonstrated that hypertonic saline inhalation modestly reduced the number of pulmonary exacerbations experienced by older children with CF (6 years or older), but less is known about the effects of this treatment in younger children.
To investigate further, Rosenfeld and team enrolled 321 children with CF who were younger than 6 years (4-60 months) to take part in the Infant Study of Inhaled Saline in Cystic Fibrosis. The trial took place between April 2009 and October 2011 across 30 CF clinics in the USA and Canada.
The children were randomly assigned to receive nebulized hypertonic saline 7.0% (n=158) or isotonic (normal) saline 0.9% twice a day for 48 weeks. All the children received albuterol or levalbuterol before being given the nebulized saline.
Rosenfeld et al report that the rate of pulmonary exacerbations (number of events per person year) was the same in the active treatment and control groups, at 2.3 events per person year
In the patients who had pulmonary exacerbations, mean duration of antibiotic treatment was longer in the active treatment group than in the control group, at 60 versus 52 days.
Pulmonary function testing was carried out in a small subgroup (n=45) and no significant differences between the two groups were seen except for a 38 mL greater forced expiratory volume in 0.5 seconds in the active group compared with the control group.
Adverse events, which were mostly cough, were similar between the two groups, at 39% in the active treatment group and 38% in the control group.
"The goal for infants and young children with no apparent or minimal CF lung disease, as opposed to older patients with established disease, should focus on prevention of disease progression rather than treatment of existing disease," suggest editorialists Elliott Dasenbrook and Michael Konstan from Case Western Reserve University School of Medicine in Cleveland, Ohio, USA.
"Rosenfeld et al have demonstrated that testing therapeutic agents in infants and young children may require different end points capable of assessing onset and progression of disease," they add.
"To make the next significant increase in survival, the CF community will again have to rise to the occasion and meet the current challenges in evaluating promising therapies. The youngest patients with CF are depending on it."
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By Helen Albert