Effect of Transdermal Tulobuterol Added to Inhaled Corticosteroids in Asthma Patients

Abstract

Tulobuterol tape is the first long-acting transdermal preparation of a p2-agonist designed to release tulobuterol in an optimal fashion over a 24-hour period. We investigated the additive effect of tulobuterol tape in adult asthma patients treated with inhaled corticosteroids. A randomized, double-blind, double-dummy, parallel-group, multicenter trial was conducted. Male and female patients with a diagnosis of asthma requiring inhaled short-acting β2-agonists despite treatment with inhaled corticosteroids took tulobuterol tape (1 mg or 2 mg) and corresponding placebo tapes for 4 weeks. Results: Mean morning peak expiratory flows (PEF) in the 1 and 2 mg/day groups were significantly increased from the baseline value by 23.8 and 35.9 L/min at week 4, respectively. The increase in mean morning PEF in the 2 mg/day group was significantly higher than that in the 1 mg/day group. The mean evening PEF was significantly increased in both treatment groups compared with baseline values. Although the increase in mean evening PEF in the 2 mg/day group was greater than that in the 1 mg/day group, the difference between groups was statistically significant only at week 1. The safety profiles of the two treatments were similar. Conclusions: In patients with persistent asthma who require inhaled short-acting β2-agonists while receiving inhaled corticosteroids, transdermal tulobuterol significantly improved PEF in a dose-dependent manner, i.e., greater effect with 2 mg than with 1 mg per day.