Purpose of the Study. A retrospective analysis comparing the efficacy and safety of nebulized budesonide inhalation suspension (Pulmicort Respules, AstraZeneca, Lund, Sweden) administered once daily by facemask or mouthpiece for mild persistent asthma.
Study Population. A total of 359 children aged 6 months to 8 years with mild, persistent asthma.
Methods. Children were randomized to receive 0.25, 0.5, or 1.0 mg budesonide inhalation suspension once daily or placebo for 12 weeks via facemask or mouthpiece. Efficacy variables included nighttime and daytime asthma symptom scores, use of breakthrough bronchodilator medications, and pulmonary function tests (in children capable of consistently performing spirometry or peak flows).
Results. Changes in nighttime and daytime asthma symptom scores were not significantly different between children using facemasks and those using mouthpieces. Use of breakthrough medications and pulmonary function test results (in the subset of children able to perform them) also were not significantly different in facemask users and mouthpiece users.
Conclusions. These results suggest that budesonide inhalation suspension is equally effective whether administered by facemask or mouthpiece and that young children who require the use of a facemask may be successfully treated.
Reviewer’s Comments. The efficacy and safety of once-daily budesonide inhalation suspension in this age group was previously reported in a multicenter, randomized, double-blind, placebo-controlled, parallel-group study (Kemp JP, Skoner D, Szefler SJ, et al. Ann Allergy Asthma Immunol. 1999;83:231–239). This study retrospectively examines the data more closely and demonstrates that efficacy and safety are not dependent on whether administration is by facemask or mouthpiece. The results here provide reassuring data for clinicians treating children with persistent asthma who are too young to use mouthpieces. Similar results have also been reported for children in this age group with moderate persistent asthma (Mellon M, Leflelin J, Walton-Bowen K, et al. Am J Respir Crit Care Med. 2000;162:593–598).
- Copyright © 2002 by the American Academy of Pediatrics