Nebulized step-down budesonide vs. fluticasone in infantile asthma: A retrospective cohort study.

The United States Food and Drug Administration has approved budesonide in infantile asthma but nebulization of infants under budesonide has the risk of relapse of asthma. The objective of the present study was to compare the effectiveness and safety of fluticasone step-down treatment with budesonide step-down treatment in infantile asthma. The data of 778 infants with confirmed asthma were included in the analysis. Infants who had received nebulized 500 µg budesonide twice daily for 6 weeks followed by 250 µg budesonide twice daily for 6 weeks were included in the BS group (n=389), while infants who had received nebulized 250 µg fluticasone twice daily for 6 weeks followed by 125 µg fluticasone twice daily for 6 weeks were included in the FC group (n=389). The data of lung function tests and a safety study were collected and analyzed. Budesonide treatment achieved a reduced specific airway resistance (sRaw; 1.28±0.11 vs. 1.21±0.10 kPa/sec; P<0.0001, q=13.45) and improved forced expiratory volume in 1 sec (FEV1; 0.977±0.068 vs. 0.997±0.085 l/sec; P<0.0001, q=5.54). In addition, fluticasone treatment achieved a reduced sRaw (1.27±0.1 vs. 1.23±0.11 kPa/sec, P<0.0001, q=7.39) and improved FEV1 (0.971±0.069 vs. 0.992±0.085 l/sec; P=0.0003, q=5.46). Of note, the efficacy of budesonide to reduce sRaw (P=0.008, q=3.69) and improve FEV1 (P<0.0001, q=6.93) was greater than that of fluticasone. The budesonide treatment group had more post-treatment symptom-free days than the fluticasone treatment group (165.56±23.15 vs. 112.21±9.45 days; P<0.0001). The step-down approach of budesonide nebulization may better support the functional and clinical outcomes with an increased number of post-treatment symptom-free days compared with fluticasone in infantile asthma (level of evidence, 3).