A Muti-center, Randomized, Double-blind, Positive Controlled Clinical Trial of Salbutamol Sulfate MDI without

【Abstract】 Objective To evaluate the efficacy and safety of domestically produced Salbutamol Sulfate metered dose inhaler (MDI) without chloro-fluro-carbon (CFC) in the treatment of asthmatic patients. Methods A muti-center,randomized, double-blind, positive controlled clinical trial was conducted in asthmatic patients. The participants were randomized divided into trial group treated with domestically produced Salbutamol Sulfate Aerosol MDI (200 μg single-dose) and control group treated with imported Salbutamol Sulfate Aerosol MDI (200 μg single-dose). The lung function was measured by spirometry and a scoring questionaire before medications and 15, 30, 120 and 240 min post medications. Results A total of 238 patients were enrolled in the trial. Compared with baselines, the forced expiratory volume in 1 s (FEV₁) of the participants in both groups increased significantly 15, 30, 120 and 240 min after medications (P<0.05). There was no significant difference in the changes of FEV₁ between the two groups (P>0.05). Similarly, the forced vital capacity (FVC) and asthma symptomatic scores of the participants in both groups improved significantly after administration of medications (P<0.05). There was no significant difference in the ratio of adverse reactions between the two groups (P>0.05). In both groups, drugs were well tolerated. Conclusion The domestically produced Salbutamol Sulfate Aerosol MDI without CFC is effective and safe for treating asthma.