Comparing the effects of two low-dose budesonide suspension nebulization treatments on asthma among young children: a multicenter study.

OBJECTIVE

To evaluate the effects of treatment with nebulized budesonide inhalation suspension (BIS) at dosages of 500 µg/day and 250 µg/day on mild to moderate asthma in young children.

METHODS

This was a randomized, parallel group, open-label study at 19 Chinese clinical sites. A total of 340 patients (4-7 years) with mild to moderate persistent pediatric asthma were randomly and evenly divided into the 500-µg group (BIS 500 µg/day) and the 250-µg group (BIS 250 µg/day); 323 patients completed the study. The Children-Asthma Control Test (C-ACT), asthma control, Pediatric Asthma Quality of Life Questionnaire (PAQLQ), pulmonary function tests (PFT), additional asthma-related therapy, and adverse effects (AEs) were compared after 1, 3, and 6 months of treatment between groups.

RESULTS

There were no statistically significant differences in C-ACT scores, level of asthma control, PAQLQ scores, PFT parameters, additional medications and AE occurrences from baseline to 6 months post-treatment between the two groups (all p > 0.05). Compared with baseline values, both groups showed improvements in C-ACT and PAQLQ scores, the rate of well-controlled asthma, and PFT parameters (all p < 0.05). The cumulative number of unplanned outpatient visits (50 vs. 49) and hospitalizations (3 vs. 0) in the 250-µg group was higher than that in the 500-µg group (p < 0.05).

CONCLUSIONS

The lower dosage of 250 µg/day BIS was found to be as effective as 500 µg/day BIS. For young children with mild to moderate persistent asthma who have well-controlled, a lower dose of BIS treatment can be chosen.