TWO-YEAR PROSPECTIVE RANDOMIZED OPEN-LABEL COMPARATIVE STUDY OF TRANSDERMAL TULOBUTEROL PATCH VERSUS INHALED SALMETEROL THERAPY COMBINED WITH INHALED BUDESONIDE ON ASTHMATIC CONTROL IN JAPANESE ADULT ASTHMATIC PATIENTS

Abstract

The efficacy of transdermal tulobuterol patch vs. inhaled salmeterol therapy with inhaled budesonide was compared in a prospective, randomized, open-label study. Asthmatic patients were randomized into 2 groups (tulobuterol group and salmeterol group).
The therapies were comparatively analyzed in Japanese adult asthmatic patients for 2 years. There was no significant difference in the backgrund was between the 2 groups. More significant improvements of the symptoms were noted in the tulobuterol group as compared with that in the salmeterol group at the endpoint.
The medical treatment cost, inflammatory cell count in bronchial alveolar lavage fluid and bronchial biopsy specimens, pulmonary function parameters, airway remodeling, Intractable Disease Related Agony (chronic pain) score, and health-related quality of life were investigated. Both the incidence of side effects and the frequency of abnormal laboratory data during this study were lower in the tulobuterol group than in the salmeterol group.
In this 2-year prospective, randomized comparative open-label study, inhaled tulobuterol therapy was found to yield better asthmatic control than inhaled salmeterol therapy when combined with budesonide.