:A MULTICENTER DOUBLE-BLIND DOUBLE-DUMMY COMPARATIVE STUDY

概要

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A multicenter, double-blind comparative study of the tulobuterol patch was conducted to evaluate the effects of continuous use of this agent on airway hypersensitivity and its safety. The participants were a total of 43 children (30 males and 13 females) with bronchial asthma aged 9 to 18 years old (mean 11.7±2.6) who received tulobuterol patch, tulobuterol oral preparation or their matching placebos for 2 weeks using a double-blind method, and whose airway hypersensitivity was evaluated by PC20 obtained before and after treatment using the standard acetylcholine inhalation method proposed by the Japanese Society of Allergology. Pre- and post-treatment PC20 differed significantly in neither the 13 children receiving tulobuterol patches nor the 16 receiving tulobuterol as an oral preparation. Tulobuterol patches appeared not to affect the airway hypersensitivity of children with bronchial asthma. The results of the study suggest that tulobuterol patches may be used for long-term control for patients with moderate persistent (Step 3) or severe persistent (Step 4) bronchial asthma according to the Guidelines for the Treatment and Management of Pediatric Bronchial Asthma in 2002. Further investigations of more long-term use of tulobuterol patches are necessary to confirm the usefulness of this agent for long-term control of childhood asthma.
日本小児アレルギー学会の論文