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Previous Volume 356:2027-2039 May 17, 2007 Number 20 Next

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

ABSTRACT

Background Treatment guidelines recommend the use of inhaled corticosteroids in patients with asthma who have persistent symptoms and the "stepping down" of therapy to the minimum needed to maintain control of asthma. Whether patients with asthma that is well controlled with the use of inhaled corticosteroids twice daily can receive a step-down treatment with once-daily montelukast (our primary hypothesis) or once-daily fluticasone propionate plus salmeterol (our secondary hypothesis) has not yet been determined.

Methods We randomly assigned 500 patients with asthma that was well controlled by inhaled fluticasone (100 µg twice daily) to receive continued fluticasone (100 µg twice daily) (169 patients), montelukast (5 or 10 mg each night) (166 patients), or fluticasone (100 µg) plus salmeterol (50 µg) each night (165 patients). Treatment was administered for 16 weeks in a double-blind manner. The primary outcome was the time to treatment failure.

Results Approximately 20% of patients assigned to receive continued fluticasone or switched to treatment with fluticasone plus salmeterol had treatment failure, as compared with 30.3% of subjects switched to montelukast. The hazard ratio for both comparisons was 1.6 (95% confidence interval, 1.1 to 2.6; P=0.03). The percentage of days on which patients were free of asthma symptoms (78.7 to 85.8%) was similar across the three groups.

Conclusions Patients with asthma that is well controlled with the use of twice-daily inhaled fluticasone can be switched to once-daily fluticasone plus salmeterol without increased rates of treatment failure. A switch to montelukast results in an increased rate of treatment failure and decreased asthma control; however, patients taking montelukast remained free of symptoms on 78.7% of treatment days. (ClinicalTrials.gov number, NCT00156819 [ClinicalTrials.gov] .)

Source Information

The members of the writing committee of the American Lung Association Asthma Clinical Research Centers (Stephen P. Peters, M.D., Ph.D., Wake Forest University, Winston-Salem, NC; Nicholas Anthonisen, M.D., the Respiratory Hospital, Winnipeg, MB, Canada; Mario Castro, M.D., Washington University, St. Louis; Janet T. Holbrook, M.P.H., Ph.D., Johns Hopkins University, Baltimore; Charles G. Irvin, Ph.D., the University of Vermont, Colchester; Lewis J. Smith, M.D., Northwestern University, Chicago; and Robert A. Wise, M.D., Johns Hopkins University, Baltimore) assume responsibility for the overall content and integrity of the article.

Address reprint requests to Dr. Holbrook at the ALA-ACRC Data Coordinating Center, 911 S. Ann St., Baltimore, MD 21231, or at jholbroo{at}jhsph.edu.

Full Text of this Article

Related Letters:

Reducing Asthma Treatment
Black P. N., Chen R., Zitt M. J., Rachelefsky G. S., Peters S. P., Castro M., Holbrook J. T.
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N Engl J Med 2007; 357:504-506, Aug 2, 2007. Correspondence

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