Clinical evaluation of a transdermal therapeutic system of the beta2-agonist tulobuterol in patients with mild or moderate persistent bronchial asthma.

Tulobuterol transdermal therapeutic system (TTS) is the world's first commercially available transdermal preparation of tulobuterol, a beta2-stimulant that can maintain effective blood tulobuterol (CAS 41570-61-0) levels for 24 h when applied once daily. In the present study, a total of 24 adult patients with mild persistent (Step 2) or moderate persistent (Step 3) bronchial asthma, consisting of 13 and 11 patients, who were or were not using inhalational steroids, respectively, used tulobuterol TTS (Hokunalin Tape) for one year and underwent measurement of peak expiratory flow (PEF) once daily. Peripheral eosinophil count, serum eosinophil cationic protein (ECP) level and airway responsiveness (Dmin) were evaluated at 6 months and 1 year, respectively, after the start of the study. PEF exhibited significant improvements after 6 months and 1 year in patients treated with or without inhalational steroids, while serum ECP was improved significantly only in the patients on inhalational steroids. Patients not using inhalational steroids exhibited significant exacerbation of Dmin at neither after 6 months nor after 1 year. One-year treatment with tulobuterol TTS did not appear to cause tachyphylaxis. The significant improvements in Dmin observed after 6 months and after 1 year in the patients using inhalational steroids suggested beneficial effects of inhalational steroids in controlling airway inflammation. Tulobuterol TTS is considered quite beneficial in improving quality of life (QOL) in patients with bronchial asthma because its incidence of adverse effects including palpitations and shivering is significantly lower than those of oral preparations because of its remarkable improvement of pulmonary function and symptoms of airway obstruction without increasing airway responsiveness even after repeated use, and because it is simple to use and ensures excellent clinical efficacy.