Objective: The objective of this study is to evaluate the efficacy and safety of Montelukast sodium in the prevention of bronchopulmonarydysplasia(BPD)
Methods: This study was designed as a multicenter, prospective, randomized, open labelled, parallel-group, intervention study. 66 infants were enrolled and allocated to Case group (n=30) and Control group (n=36) by random assignment stratified by gestational age (GA) (≥28 weeks, <28 weeks). Assigned to the Case group, infants were given Montelukast sodium (Singulair®) according to the body weight(BW). Day 0 was defined as the start time of the study.
Results: There was no difference in BW (case 1097g±327.3 vs. control 997g±235.3, p=0.153) and GA(case 27.6±1.4weeks vs. control 27.3±1.6weeks, p=0.374) between the two groups. The incidences of moderate to severe BPD were not remarkably different between the groups. (case 13/30 (43.3%) vs. control 19/36 (52.8%), p=0.912). The ventilaton index between the two groups were not significantly different at neither day 0 (Case 17.5±9.6 vs. control 23.7±8.8, p=0.141) nor day 28 (case 12.8 vs. control 28.5, p=not applicapable). The use of systemic steroid was not different either (case 7/30 (23.3%) vs. control 7/36 (19.4%), p=0.768). There was no serious adverse drug event, and no statistically significant difference (case 10/42 (23.8%) vs. control 6/48 (15.8%) p=0.414). Modeling reveals that the volume of distribution decreases as the serum creatinine concentration increseases, and the clearance decreases as the age increases
Conclusions: Montelukast was not effective in reducing the moderate or severe BPD. Additionally, there was no significant increase of adverse drug event. associated with montelukast treatment. And we suggest pharmacokinetic study of Montelukast sodium.
