Effects of the addition of Beta2-agonist tulobuterol patches to inhaled corticosteroid in patients with asthma.

BACKGROUND: Whether the additive effects of the tulobuterol patch (TP), the world's first transdermal beta2-agonist preparation, are useful in asthma patients receiving inhaled corticosteroid (ICS) is unclear. To examine the add-on effects of TP on bronchial hyperresponsiveness and reduction of the percentage of sputum eosinophils, and to compare add-on effects of TP, slow-release theophylline (SRT), and a leukotriene receptor antagonist (LTRA) in patients with asthma receiving ICS. METHODS: Study 1: We randomly allocated 24 patients with asthma receiving ICS alone in equal numbers to either control treatment (ICS alone at conventional doses) or TP treatment (ICS at conventional doses plus TP at 2mg/day). Following a 2-week observation period, patients received the allocated drug regimens for 4 weeks. Methacholine challenge test and measurement of percentage of eosinophils in hypertonic saline-induced sputum were performed before and after the treatment period. Study 2: We compared add-on effects of TP, SRT, and LTRA in 65 patients with asthma receiving ICS alone, using spirometry and peak expiratory flow (PEF). Participants in these studies had experienced decrease in morning PEF to <80% of the predicted value at least twice a week. RESULTS: Study 1: In the TP group, improvement of bronchial hyperresponsiveness and decrease in percentage of sputum eosinophils both indicated a statistically significant difference (p < 0.01, and p < 0.05, respectively). These findings were not observed in the control group. Study 2: forced expiratory volume in 1 second (FEV(1)) and PEF markedly increased after treatment with TP compared with treatment with SRT or LTRA. CONCLUSIONS: These findings suggest that TP can be used as a long-term add-on controller for patients with asthma receiving ICS.