Abstract: Objective: To evaluate the effectiveness and safety of generic nebulized salbutamol in children with acute wheezing. Methods: This was a non-randomized controlled trial. Patients younger than 18 years old with acute wheezing episodes were divided into the original drug group ［5 mg·(2 mL)-1 albuterol inhalation solution, produced by GSK company］ and the generic drug group ［2.5 mg·（2.5 mL)-1 albuterol sulfate nebulized inhalation solution, produced by Shanghai Xinyi Jinzhu Pharmaceutical Co., Ltd.］ according to the actual clinical prescriptions. The dose and administration were the following: a. 2.5 mg each time for those with weight≤20 kg or 5.0 mg each time for those with weight >20 kg; b. compatible with normal saline or other nebulized drugs (according to actual clinical needs) to 4 mL liquid, driven by oxygen flow 6 to 8 L·min-1 or air compression pump, twice a day for 3 days. Each participant recorded a log every day. The primary outcome was the difference in clinical symptom severity (ΔCS) each day, and the secondary outcome was the adverse event such as arrhythmia, muscle tremor or diarrhea. Results: A total of 841 outpatients consulting in Children's Hospital of Fudan University from February 2018 to June 2019 with acute wheezing were included, 438 cases in the original group and 403 cases in the generic group. All patients completed the follow-up period. The baseline items (gender, age, main diagnosis, compatibility of nebulized medications and combined systemic medication) with statistically significant differences between the two groups were treated as a covariate of the propensity score. According to 1∶1 matching and the matching tolerance set as 0.1, there were 299 cases left in each group. ΔCS each day in both groups decreased over time ［（-0.38±0.48）vs(-0.43±0.49)vs(-0.58±0.49）for 3 days in the original group, (-0.47±0.50)vs(-0.50±0.50)vs(-0.59±0.49) for 3 days in generic group］. There were statistically significant differences in ΔCS among 3 days in both groups. The ΔCS on day 3 was significantly lower than that on day 1 and day 2 in both groups. There was a statistically significant difference in the ΔCS scores between the two groups on the first day, and there was no significant difference in the ΔCS scores on the second or the third day. Among the 841 children with acute wheezing, there were no cases withdrawing from observation because of serious adverse reactions. Proportion of tremors was 2.5% (11/438) in original group and 4.5% (18/403) in the generic drug , and that of diarrhea was 0.7% (3/438) in the original group and 1.5% (6/403) in the generic drug group. The differences were not statistically significant. Conclusion: Generic salbutamol is not less effective than the original drug in relieving children's acute wheezing, and they have similar frequency of adverse events.