Effective Once-Daily Administration of Budesonide Inhalation Suspension by Nebulizer with Facemasks or Mouthpieces for Persistent Asthma in Infants and Young Children

This study is a retrospective analysis comparing nebulized budesonide inhalation suspension (BIS; Pulmicort Respules™, AstraZeneca, Wilmington, DE) administered once daily by facemask or mouthpiece in 359 infants and young children with persistent asthma. The efficacy and safety of once-daily BIS (0.25, 0.5, and 1.0 mg) administered by facemask or mouthpiece were demonstrated in a multicenter, randomized, double-blind, placebo-controlled, parallel-group study reported by Kemp et al. (Ann Allergy Asthma Immunol 1999; 83:231–239). Three hundred fifty-nine children aged 6 months to 8 years with mild, persistent asthma received nebulized BIS 0.25, 0.5, or 1.0 mg 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). 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. These results suggest that BIS is equally effective whether administered by facemask or mouthpiece and that young children who require the use of a facemask may be successfully treated.