Objective: To evaluate the efficacy and safety of tulobuterol tape in mild and moderate persistent asthma patients.
Methods: A multicenter, randomized, controlled, open label study was performed. A total of 233 adult patients with mild and moderate persistent asthma were enrolled, and 115 patients were treated with tulobuterol tape and 118 with tulobuterol tablet.
Result: After 4 weeks of treatment, the morning peak expiratory flow (PEF) and evening PEF and the percent change in the tulobuterol tape group were increased significantly as compared to the tulobuterol tablet group (P < 0.05). The rate of improvement in morning PEF with the tape group and the tablet group were 9.1 (0.38 approximately 19.4)% and 4.2 (-6.4 approximately 18.3)%, respectively. The pulmonary function, variation rate of PEF, asthma score and usage of short-acting beta(2) agonist were improved after 4 weeks of treatment, but the differences were not significant between the two groups. The incidence of adverse reactions including palpitations and tremor in the tulobuterol tape group was significantly lower than that in the tablet group (chi(2) = 7.0919, P = 0.0077), and the incidence of local skin adverse reactions in tape group was 2.6%.
Conclusion: Tulobuterol tape is a newly formulated, effective and safe medication for the treatment of asthma.