LAUSR

Abstract Purpose The aim of this study was to investigate the efficacy and safety of tratinterol hydrochloride in bronchial asthma (BA) treatment. Methods Patients enrolled in this study were distributed randomly into a treatment group (tratinterol hydrochloride) and an active control group (procaterol hydrochloride) and were treated for 2 weeks after running-in. The end points were changes in pulmonary function and clinical symptoms after administration. Safety indices were physical examinations, laboratory testing and spontaneous reporting. Findings We enrolled 732 subjects, −365 in the treatment group and 367 in the active control group. Forced expiratory volume (FEV1), significantly increased in both group after treatment (P < 0.05). Least-squares (LS) means were −0.03/in the full-analysis set (FAS) and −0.02 in the per-protocol set (PPS) set, and 95% confidence intervals (CIs) for these sets were −0.09 to 0.03 and −0.08 to 0.04, respectively. Forced expiratory volume (FVC), morning peak expiratory flow (PEF) and asthma scores were significantly different with pretreatment (P < 0.05). There was no difference in asymptomatic days or frequency of relief medicine use (P > 0.05). No serious adverse events occurred. Implications Tratinterol hydrochloride was effective, safe and not inferior to procaterol hydrochloride in treating BA.