Randomized comparison of strategies for reducing treatment in mild persistent asthma

Stephen P. Peters, Nicholas Anthonisen, Mario Castro, Janet Teresa Holbrook, Charles G. Irvin, Lewis J. Smith, Robert A Wise

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)2027-2039
Number of pages13
JournalNew England Journal of Medicine
Volume356
Issue number20
DOIs
StatePublished - May 17 2007

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montelukast
Asthma
Treatment Failure
Therapeutics
Adrenal Cortex Hormones
Fluticasone
Guidelines
Confidence Intervals

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Randomized comparison of strategies for reducing treatment in mild persistent asthma. / Peters, Stephen P.; Anthonisen, Nicholas; Castro, Mario; Holbrook, Janet Teresa; Irvin, Charles G.; Smith, Lewis J.; Wise, Robert A.

In: New England Journal of Medicine, Vol. 356, No. 20, 17.05.2007, p. 2027-2039.

Research output: Contribution to journalArticle

Peters, Stephen P. ; Anthonisen, Nicholas ; Castro, Mario ; Holbrook, Janet Teresa ; Irvin, Charles G. ; Smith, Lewis J. ; Wise, Robert A. / Randomized comparison of strategies for reducing treatment in mild persistent asthma. In: New England Journal of Medicine. 2007 ; Vol. 356, No. 20. pp. 2027-2039.
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AB - 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.

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