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

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.)

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  • Authors+Show Affiliations

    ,

    Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, Australia.

    , , , , , , , ,

    Source

    The New England journal of medicine 354:3 2006 Jan 19 pg 229-40

    MeSH

    Absenteeism
    Administration, Inhalation
    Adolescent
    Adult
    Albuterol
    Anti-Bacterial Agents
    Bronchodilator Agents
    Child
    Cough
    Cystic Fibrosis
    Disease-Free Survival
    Double-Blind Method
    Drug Therapy, Combination
    Female
    Forced Expiratory Volume
    Humans
    Isotonic Solutions
    Male
    Maximal Midexpiratory Flow Rate
    Premedication
    Saline Solution, Hypertonic
    Sodium Chloride
    Treatment Outcome
    Vital Capacity

    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 - https://www.nejm.org/doi/10.1056/NEJMoa043900?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=www.ncbi.nlm.nih.gov DB - PRIME DP - Unbound Medicine ER -