RESUMEN
OBJECTIVE: To evaluate the clinical efficacy and safety of domestic inhaled N-acetyl-L-cysteine (NAC) solution in mucolytic therapy. METHODS: This was a multi-centre, randomized, double blinded and positive parallel trial. Fluimucil, an imported drug with the same active ingredient was used as control. Two hundred and thirty-four patients suffering from acute and chronic lower respiratory tract infection were enrolled, 117 patients in study group and control group respectively. Both groups were treated by respective drug 3 mL given by inhalation, bid, for 5-7 d. Non-inferiority test and two-sided test were used to analyze the statistic difference. RESULTS: The effective rates of the study group were 74.8% (PPS) and 74.1% (FAS). There was no significant difference (P > 0.05) between the two groups. There were no serious adverse events and major adverse events during the study. The incidence of adverse events in study group was 14.5%. There was no significant difference (P > 0.05) between the two groups. According to the preset non-inferior creteria, ie 15%, the non-inferiority of the test drug was established. CONCLUSION: The clinical efficacy and safety of the domestive inhaled N-acetyl-L-cysteine solution in mucolytic therapy are equal to fluimucil.