Randomized double-blind control multicenter clinical study of levalbuterol hydrochloride in the treament of mild-moderate asthma
10.3969/j.issn.1001-6821.2009.04.001
- VernacularTitle:盐酸左旋沙丁胺醇治疗轻、中度支气管哮喘的随机双盲对照多中心临床研究
- Author:
Jin-Fang MA
1
;
Zi-Wen ZHAO
;
Ben-Tong YUAN
;
Ping-Yan CHEN
;
Jin-Ping ZHENG
Author Information
1. 广州医学院附属第一医院
- Keywords:
levalbuterol hydrochloride;
salbutamol sulphate;
asthma
- From:
The Chinese Journal of Clinical Pharmacology
2009;25(4):291-293,297
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of levalbuterol hydrochloride in the treatment of mild - moderate asthma. Methods Randomized double -blind, control clinical study was carried out. One hundred twenty- two mild- moderate asthma patients were randomized to enroll the study. Trial group was treated with oral Ievalbuterol hydrochlo-ride tablets 1.15 nag thrice daily. Control group was treated with oral sal-butamol sulphate tablets 2 mg thrice daily. The therapy window is ( 14 ±2) d. Results Comparison with baseline, the first forced expiratory vol-ume vs predicted( FEV1% ), the first forced expiratory volume (FEV1)and the first forced expiratory volume vs the forced vital capacity (FEV1/FVC) were obviously improved in trial group. There is significantly statis-ties difference (P≤0. 05 ). Control group has no significant variance pre and post treatment. Drug adverse reaction of trial group and control group is 12.5% and 15.3% ,respectively. There is no marked difference between two groups. Conclusion Two groups are equivalent in the treatment of mild to moderate asthma, moreover, lung function has been more improved greatly in trial group compared with control group.
