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A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis.
N Engl J Med 2006; 354(3):229-40NEJM

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 [FEF25-75]) 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 FEF25-75 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.)

Authors+Show Affiliations

Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, Australia.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16421364

Citation

Elkins, Mark R., et al. "A Controlled Trial of Long-term Inhaled Hypertonic Saline in Patients With Cystic Fibrosis." The New England Journal of Medicine, vol. 354, no. 3, 2006, pp. 229-40.
Elkins MR, Robinson M, Rose BR, et al. A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis. N Engl J Med. 2006;354(3):229-40.
Elkins, M. R., Robinson, M., Rose, B. R., Harbour, C., Moriarty, C. P., Marks, G. B., ... Bye, P. T. (2006). A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis. The New England Journal of Medicine, 354(3), pp. 229-40.
Elkins MR, et al. A Controlled Trial of Long-term Inhaled Hypertonic Saline in Patients With Cystic Fibrosis. N Engl J Med. 2006 Jan 19;354(3):229-40. PubMed PMID: 16421364.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis. AU - Elkins,Mark R, AU - Robinson,Michael, AU - Rose,Barbara R, AU - Harbour,Colin, AU - Moriarty,Carmel P, AU - Marks,Guy B, AU - Belousova,Elena G, AU - Xuan,Wei, AU - Bye,Peter T P, AU - ,, PY - 2006/1/20/pubmed PY - 2006/1/25/medline PY - 2006/1/20/entrez SP - 229 EP - 40 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 354 IS - 3 N2 - 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 [FEF25-75]) 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 FEF25-75 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.) SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/16421364/full_citation L2 - http://www.nejm.org/doi/full/10.1056/NEJMoa043900?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -