The Science Journal of the American Association for Respiratory Care

1998 OPEN FORUM Abstracts

BUDESONIDE NEBULIZING SUSPENSION (BNS; PULMICORT RESPULES^{TM}) IMPROVES PULMONARY FUNCTION IN YOUNG CHILDREN WITH PERSISTENT ASTHMA NOT WELL-CONTROLLED ON OTHER INHALED GLUCOCORTICOSTEROIDS (IGCs).

M. Cruz-Rivera, Ph.D., M.P.H. & K. Walton-Bowen, M.Sc., C.Stat. (Astra USA, Inc., Westborough, MA).

The current NHLBI guidelines highlight the importance of managing pediatric persistent asthma with antiinflammatory agents, including IGCs. Budesonide is a GCS with low systemic-to-local-effects ratio formulated for use via nebulizer in pediatric persistent asthma. This was a randomized, double-blind, placebo (PBO)-controlled, multicenter, 12-wk study assessing the efficacy and safety of BNS (0.25, 0.5 or 1.0 mg BID) in 178 children aged 4-8 yrs with persistent asthma not well-controlled on IGCs via pMDI. Compared to PBO, there were improvements in lung function (mean change from baseline over 12 wks, adjusted for center effect; All Patients Treated; last value carried forward):

PBO BNS (BID)

Variable 0.25 mg 0.5 mg 1.0 mg

(n=41) (n=46) (n=42) (n=45)

Morning PEF (L/min): -1.3 15.3** 11.8* 10.4*

(n=44) (n=47)

Evening PEF (L/min): 3.0 14.9* 11.6 13.2

(n=44) (n=47)

FEV_{1} (L): -0.01 0.05 0.08* 0.07

FEF_{25-75%} (L/sec): -0.06 0.00 0.14* 0.14*

FVC (L) 0.04 0.09 0.06 0.05

(p(0.050, **p(0.010, and ***p(0.001 vs. PBO)

In addition, there were statistically significant improvements in nighttime and daytime asthma symptoms, and statistically significant reductions in the use of bronchodilators in all three BNS treatment groups compared to PBO (p(0.032). These data support the efficacy of BNS in persistent pediatric asthma not well-controlled on other IGCs via pMDI. Supported by Astra USA, Inc.

The 44th International Respiratory Congress Abstracts-On-DiskĀ®, November 7 - 10, 1998, Atlanta, Georgia.

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