The aim of this study was to investigate the efficacy and safety of tratinterol hydrochloride in bronchial asthma (BA) treatment. 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. We enrolled 732 subjects, −365 in the treatment group and 367 in the active control group. Forced expiratory volume (FEV 1 ), 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. Tratinterol hydrochloride was effective, safe and not inferior to procaterol hydrochloride in treating BA.