Abstract
Children (6 to 15 years old) with mild to moderate persistent asthma who inadequately responded to inhaled corticosteroid treatment (beclomethasone or fluticasone, 100 μg/day) were concomitantly administered a patch formulation of tulobuterol (1 or 2 mg/day), a long-acting beta-2 agonist, for 12 weeks, and its usefulness as an add-on therapy (n=17) was compared with that of double-dose inhaled corticosteroid therapy (n=13). The group concomitantly administered the tulobuterol patch showed significant improvement in %PEF on awakening during the subsequent 1 to 12 weeks as compared with the observation period, with a significant difference in %PEF on awakening at week 7 as compared with the group that received increased inhaled corticosteroid. Moreover, although no significant differences were seen between the groups with respect to bedtime %PEF, asthma symptoms, or quality of life, improvement as compared with the observation period was seen for these measures. Safety with add-on administration of the tulobuterol patch was high. The only adverse events that occurred were itching and skin rash in 2 patients. Although the tulobuterol patch is recommended as an add-on therapy for persistent childhood asthma of moderate or greater severity in the Japanese Pediatric Guideline for the Treatment and Management of Asthma (JPGL) 2012, the present results suggest that add-on treatment with the patch may also be an option for children with mild persistent asthma.
