Asthma diagnosis and treatment
Asthma control can be maintained when fluticasone propionate/salmeterol in a single inhaler is stepped down

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Background

Asthma control is the goal of treatment, but little data exist to support treatment strategies for stepping down treatment once control has been achieved.

Objective

We assessed whether either the long-acting β2-agonist or corticosteroid could be reduced without loss of asthma control once control had been attained with fluticasone propionate/salmeterol (FSC).

Methods

After 12 weeks of open-label treatment with FSC 250/50 μg twice daily, patients whose asthma was well controlled were randomized to FSC 100/50 μg twice daily or fluticasone propionate (FP) 250 μg twice daily. for 12 weeks. The primary endpoint was mean morning peak expiratory flow over the randomized study period. Secondary endpoints included symptom scores, rescue albuterol use, and asthma control.

Results

During open-label treatment, improvements from baseline were seen, and 435 of 641 patients (68%) achieved well controlled status during each of the last 4 weeks of this period. A total of 246 patients received FSC 100/50 μg twice daily and 238 FP 250 μg twice daily. The adjusted mean change in morning peak expiratory flow from the end of open-label treatment was −0.3 L/min for FSC and −13.2 L/min for FP (treatment difference, 12.9 L/min; 95% CI, 8.1-17.6; P < .001). Secondary efficacy endpoints also showed FSC 100/50 μg twice daily to be more effective than FP 250 μg twice daily alone. The majority of patients remained well controlled, but the proportion was higher with FSC.

Conclusion

In patients achieving asthma control with FSC 250/50 μg twice daily, stepping treatment down to a lower dose of FSC 100/50 μg twice daily is more effective than switching to an inhaled corticosteroid alone.

Section snippets

Study design

After a 2-week run-in period, this multicenter study had 2 treatment phases (Fig 1). Patients whose asthma was assessed as well controlled in each of the last 4 weeks of 12 weeks of open-label treatment with FSC (ADVAIR/SERETIDE/VIANI; GlaxoSmithKline, Greenford, United Kingdom) 250/50 μg twice daily were randomized into a 12-week, double-blind, parallel-group phase (step-down phase) comparing FSC 100/50 μg twice daily (inhaled corticosteroid reduced) with FP 250 μg twice daily (long-acting β2

Patient characteristics

A total of 855 patients were screened, 641 patients were included in the open-label phase, and 484 patients (246 treated with FSC and 238 treated with FP) were included in the ITT population for the double-blind step-down phase (Fig 2). Two hundred eight patients treated with FSC and 188 treated with FP were included in PP analyses.

Baseline characteristics at study entry and during run-in were similar for all patients entering the open-label phase and for randomized patients (Table I). The mean

Discussion

Current international asthma guidelines1 recommend that once asthma control has been achieved and maintained for 3 to 6 months, treatment should be reviewed and dose reduction of controller medication should be attempted, with careful monitoring to ensure that control is not lost. This advice is largely based on clinical experience, and few studies have examined the options and most favorable conditions for stepping down treatment. Questions that need to be addressed include whether step-down

References (16)

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Supported by GlaxoSmithKline R & D Limited.

Disclosure of potential conflict of interest: L. Jaques and M. Duggan are employed with and own stock in GlaxoSmithKline. E. D. Bateman has consultant arrangements with Boehringer Ingelheim, Pfizer, Aventis, Hoffmann le Roche, and GlaxoSmithKline; is on the speakers' bureau for AstraZeneca, Altana, Boehringer Ingelheim, GlaxoSmithKline, and Merck; and is on the advisory board for AstraZeneca, Altana, Boehringer Ingelheim, GlaxoSmithKline, and Hoffmann le Roche. C. Goldfrad is employed by GlaxoSmithKline. T. Atienza is on the speakers' bureau of GlaxoSmithKline Philippines Inc. T. Mihaescu has consultant arrangements with GlaxoSmithKline, AstraZeneca, and Merck Sharp Dohme and has received research support from GlaxoSmithKline.

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