Efficacy and safety of tratinterol hydrochloride tablets in bronchial asthma: a randomized double-blind and multicenter clinical trial

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.

Keywords:

• Tratinterol hydrochloride
• β2 adrenergic receptor agonist
• bronchial asthma
• multicenter clinical study

Acknowledgements

This study was a multicenter clinical trial, and its completion required the efforts of all study sites. We would like to thank the study investigators at each site (The First Hospital of China Medical University, The Center Hospital of Baotou, The Affiliated Hospital of Inner Mongolia Medical University, Daqing General Hospital Group Oilfield General Hospital, The General Hospital of Shenyang Military, People's Hospital of Tianjin, Lanzhou University Second Hospital, The 251st Hospital of PLA, The Second Hospital of Dalian Medical University, The Second Affiliated Hospital of Harbin Medical University, Qingdao Municipal Hospital, The Center Hospital of Siping, Wu Xi People's Hospital, Anhui Provincial Hospital, Xiehe Hospital Affiliated to Tongji Medical college, Huazhong University of Science and Technology, The First Affiliated Hospital of HarBin Medical University, and The Third Xiangya Hospital) for their outstanding work in conducting the trial.

The investigators contributed to study supervision, review of the data, writing of the clinical study report, and patient recruitment. We would also like to thank the study leaders of each site who organized the trial, made decisions during the study and allowed it to proceed well. Additionally, we thank the Department of Health Statistics of Peking University, Beijing, China, for processing the clinical data statistics; Jinzhou Jiutai Pharmaceutical Co., Ltd for providing all study drugs and for their financial support in the treatment and Shenyang Pharmaceutical University, Shenyan, China, for developing the drug for clinical study. All authors contributed equally to the study, had unlimited access to the clinical study report and statistical analysis, contributed to interpretation of the data and were involved in every stage of manuscript preparation. In addition, all authors made final decisions on all aspects of the article, and hence, are in agreement with, and approve, the final version of the submitted article.

We thank LetPub (www.letpub.com) for its linguistic assistance during the preparation of this manuscript.

Disclosure statement

The study drugs were provided by Jinzhou Jiutai Pharmaceutical Company, Ltd. The authors have indicated that they have no conflicts of interest with regard to the content of this article.