Usefulness of Tulobuterol Patch in Long-Term Management of Mild to Moderate Persistent Childhood Bronchial Asthma: Multicenter, Open-Label, Parallel-Group Comparison of Add-On Tulobuterol Patch and Increased Inhaled Corticosteroid Dose (PEACOC Study)

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.