Abstract
Tulobuterol tape is the first transdermal preparation of long-acting β2 agonist in the world. When it is applied once a day, blood concentration of tulobuterol and its effect last for 24 hours. Tulobuterol tape prevents morning dip fairly well by application at bedtime, and is more tolerated than oral preparations.
Objective: To investigate the efficacy of tulobuterol tape in addition to inhaled corticosteroids in adult patients with bronchial asthma and to confirm its optimal dose.
Design: A multicenter, randomised, double-blind, parallel-group comparison study
Subjects: Patients with bronchial asthma aged ≥16 years (n=239) whose peak expiratory flow (PEF) in the morning was ≥15% lower than evening PEF despite usual treatment.
Methods and Results: After a 2-week run-in period, patients were randomised to apply either a tulobuterol 1 mg tape and 2 mg placebo or a tulobuterol 2 mg tape and 1 mg placebo once a day at bedtime for 4 weeks. Morning PEF in the 1 and 2 mg group increased significantly from the baseline by 23.8 and 35.9 L/min at week 4, respectively. The increase in morning PEF was significantly higher in the 2 mg group than in the 1 mg group. Evening PEF was also significantly higher than baseline at all time-points in both groups as well as morning PEF. The improvement rate was significantly higher in the 2 mg group than in the 1 mg group. There were no serious adverse events.
Conclusion: These results indicated that tulobuterol tape is effective as a long-acting β2-agonist for asthma treatment when combined with inhaled steroids and the optimal dose in Japanese patients appears to be 2 mg/day.