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Tapering Dose of Inhaled Budesonide in Subjects with Mild-to-Moderate Persistent Asthma Treated with Montelukast: A 16-Week Single-Blind Randomized Study

Address correspondence to Graziano Riccioni, M.D., Ph.D., Via S. Moffa, 61 CP 188, 71016 San Severo (FG), Italia; tel 39 333 636 6661; fax 39 0882 225 537; e-mail: griccioni{at}hotmail.com.

Pharmacological therapy with inhaled steroids (IS) is currently considered the gold-standard of treatment for mild-persistent asthma. Leukotriene receptor antagonist drugs (LTRAs) play an important role associated with IS, allowing dose tapering and maintaining control of asthma symptoms. The aim of this study was to determine the effectiveness of montelukast (MON) to allow tapering of the inhaled dose of budesonide (BUD) in patients with mild-moderate persistent asthma. This 16-wk single-blind randomized study included 40 asthmatic patients divided in 2 treatment groups. After a run-in period (4 wk), in which all patients inhaled 400 µg of BUD twice daily (bid), group A (20 patients) received MON (oral, 10 mg/day) combined with inhaled BUD (400 µg/bid), while group B (20 patients) was treated with BUD for the whole period of the study. In both groups, at every 4 wk the dose of BUD was halved. After 12 wk of treatment the mean value of forced expiratory volume during the first sec (FEV1, as % of predicted value) was significantly greater in group A compared with group B (94 ± 7.5 vs 83.1 ± 6.9; p<0.005). The mean values of peak expiratory flow (PEF), the percentages of asthmatic exacerbations, and the use of ß₂-short-acting agonist (SABA) were similar in the 2 groups at 4, 8, and 12 wk. In conclusion, in patients with mild-moderate persistent asthma, MON therapy is useful in tapering the dose of IS in order to reduce its side effects and to maintain the clinical stability of the disease.

Keywords: montelukast, budesonide, asthma therapy, leukotrienes

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				S Joos, A Miksch, J Szecsenyi, B Wieseler, U Grouven, T Kaiser, and A Schneider Montelukast as add-on therapy to inhaled corticosteroids in the treatment of mild to moderate asthma: a systematic review Thorax, May 1, 2008; 63(5): 453 - 462. [Abstract] [Full Text] [PDF]