A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis

Elkins, Mark R., Robinson, Michael, Rose, Barbara R., Harbour, Colin, Moriarty, Carmel P., Marks, Guy B., Belousova, Elena G., Xuan, Wei, Bye, Peter T. P., for the National Hypertonic Saline in Cystic Fibrosis (NHSCF) Study Group and Wainwright, C. (2006) A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis. New England Journal of Medicine, 354 3: 229-240.


Author Elkins, Mark R.
Robinson, Michael
Rose, Barbara R.
Harbour, Colin
Moriarty, Carmel P.
Marks, Guy B.
Belousova, Elena G.
Xuan, Wei
Bye, Peter T. P.
for the National Hypertonic Saline in Cystic Fibrosis (NHSCF) Study Group
Wainwright, C.
Title A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis
Journal name New England Journal of Medicine   Check publisher's open access policy
ISSN 1533-4406
0028-4793
Publication date 2006-01-19
Sub-type Article (original research)
DOI 10.1056/NEJMoa043900
Volume 354
Issue 3
Start page 229
End page 240
Total pages 12
Place of publication Boston, MA, U.S.A.
Publisher Massachusetts Medical Society
Language eng
Subject 320100 Medicine - General
Formatted 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 [FEV(sub 1)], and forced expiratory flow at 25 to 75 percent of FVC [FEF(sub 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 FEV(sub 1) (by 68 ml; 95 percent confidence interval, 3 to 132) values, but similar FEF(sub 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.
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Excellence in Research Australia (ERA) - Collection
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