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(Chest. 2005;127:117-124.)
© 2005 American College of Chest Physicians

Step-Down Compared to Fixed-Dose Treatment With Inhaled Fluticasone Propionate in Asthma*

Antonio Foresi, MD; Berardino Mastropasqua, MD; Alfredo Chetta, MD, FCCP; Raffaele D’Ippolito, MD; Renato Testi, MD; Dario Olivieri, MD, FCCP and Andrea Pelucchi, MD

* From the Respiratory Pathophysiology Unit (Drs. Foresi, Mastropasqua, and Pelucchi), Sesto San Giovanni Hospital, Sesto San Giovanni; Department of Clinical Sciences (Drs. Chetta, D’Ippolito, and Olivieri), Section of Respiratory Diseases, University of Parma, Parma; and Research & Development Unit (Dr. Testi), Glaxo-Smith-Kline, Verona, Italy.

Correspondence to: Antonio Foresi, MD, Servizio di Pneumologia e Fisiopatologia Respiratoria, Viale Matteotti 83, 20099 Sesto San Giovanni, Italy; e-mail: antonio.foresi{at}aovimercate.org

Background: Inhaled corticosteroids (ICSs) are an effective treatment of asthma even when administered at a low dose. Once asthma is controlled, current guidelines recommend that the dose of ICS be reduced to the lowest possible and effective dose. Although the most appropriate strategy for the stepping down has not yet been defined, quantification of sputum eosinophils and bronchial hyperresponsiveness (BHR) are indeed measures of asthma control.

Objective: To compare the efficacy of step-down and fixed-dose strategies in the control of BHR to methacholine and eosinophilic inflammation patients with mild-to-moderate asthma.

Methods: We performed a double-blind, randomized study to compare inhaled fluticasone propionate (FP), 1,000 µg/d, then reduced to 200 µg/d (group 1; n = 18) to a fixed dose of FP, 200 µg/d (group 2; n = 17) administered for 6 weeks and then 8 weeks in reducing the provocative dose of methacholine causing a 20% fall in FEV1 (PD20) and sputum eosinophils in 35 patients. The duration of the efficacy was also followed subsequently after 8 weeks of placebo treatment.

Results: PD20 remarkably increased with both treatment strategies, but differences between groups were not significant. Sputum eosinophils (median values, percentage) at baseline and after each treatment period were not different (group 1, 16.4 to 1.0 to 2.7%; group 2, 16.7 to 2.8 to 2.8%, respectively). The percentages of patients in whom sputum eosinophilia was normalized (≤ 3%) were as follows: group 1, 69% and 60%; group 2, 50% and 57%. After placebo treatment, sputum eosinophils were still "normalized" in approximately one third of patients.

Conclusion: Step-down and fixed-dose strategies with FP improved PD20 and sputum eosinophilia to a similar degree. The effect on sputum eosinophils persisted longer than that on methacholine.

Key Words: asthma • fluticasone propionate • inhaled steroids • sputum eosinophils






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