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Previous Volume 354:229-240 January 19, 2006 Number 3 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Editorial by Ratjen, F. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Inhaled hypertonic saline acutely increases mucociliary clearance and, in short-term trials, improves lung function in people with cystic fibrosis. We tested the safety and efficacy of inhaled hypertonic saline in a long-term trial.

Methods In this double-blind, parallel-group trial, 164 patients with stable cystic fibrosis who were at least six years old were randomly assigned to inhale 4 ml of either 7 percent hypertonic saline or 0.9 percent (control) saline twice daily for 48 weeks, with quinine sulfate (0.25 mg per milliliter) added to each solution to mask the taste. A bronchodilator was given before each dose, and other standard therapies were continued during the trial.

Results The primary outcome measure, the rate of change (slope) in lung function (reflected by the forced vital capacity [FVC], forced expiratory volume in one second [FEV₁], and forced expiratory flow at 25 to 75 percent of FVC [FEF_25–75]) during the 48 weeks of treatment, did not differ significantly between groups (P=0.79). However, the absolute difference in lung function between groups was significant (P=0.03) when averaged across all post-randomization visits in the 48-week treatment period. As compared with the control group, the hypertonic-saline group had significantly higher FVC (by 82 ml; 95 percent confidence interval, 12 to 153) and FEV₁ (by 68 ml; 95 percent confidence interval, 3 to 132) values, but similar FEF_25–75 values. The hypertonic-saline group also had significantly fewer pulmonary exacerbations (relative reduction, 56 percent; P=0.02) and a significantly higher percentage of patients without exacerbations (76 percent, as compared with 62 percent in the control group; P=0.03). Hypertonic saline was not associated with worsening bacterial infection or inflammation.

Conclusions Hypertonic saline preceded by a bronchodilator is an inexpensive, safe, and effective additional therapy for patients with cystic fibrosis. (ClinicalTrials.gov number, NCT00271310 [ClinicalTrials.gov] .)

Source Information

From the Department of Respiratory Medicine, Royal Prince Alfred Hospital (M.R.E., M.R., C.P.M., P.T.P.B.); the Departments of Medicine (M.R.E., G.B.M., P.T.P.B.) and Microbiology and Infectious Diseases (B.R.R., C.H.), University of Sydney; and the Woolcock Institute of Medical Research (G.B.M., E.G.B., W.X., P.T.P.B.) — all in Sydney.

Address reprint requests to Dr. Bye at the Department of Respiratory Medicine, Level 11 E Block, Royal Prince Alfred Hospital, Missenden Rd., Camperdown 2050, Australia, or at peterb{at}med.usyd.edu.au.

Full Text of this Article

Related Letters:

Hypertonic Saline for Cystic Fibrosis
Aziz I., Kastelik J. A., Zarogiannis S., Hatzoglou C., Gourgoulianis K., Kuver R., Lee S. P., Bye P. T.P., Elkins M. R., Donaldson S. H., Tarran R., Boucher R. C., Ratjen F.
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N Engl J Med 2006; 354:1848-1851, Apr 27, 2006. Correspondence

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