title: [A multi-center, randomized, double-blind, positive controlled clinical trial of salbutamol sulfate MDI without CFC in the treatment of asthma].
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 muticenter, 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 microg single-dose) and control group treated with imported Salbutamol Sulfate Aerosol MDI (200 microg 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.
  
  
  CONCLUSIONS
  The domestically produced Salbutamol Sulfate Aerosol MDI without CFC is effective and safe for treating asthma.
mesh_terms: D000420:Albuterol / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D004311:Double-Blind Method; D005541:Forced Expiratory Volume; D006801:Humans; D036501:Metered Dose Inhalers
chemical_list: D000420:Albuterol