Comparable efficacy of administration with face mask or mouthpiece of nebulized budesonide inhalation suspension for infants and young children with persistent asthma

A randomized, double-blind, placebo-controlled, parallel-group study includ ing 481 children at 37 centers in the United States demonstrated the effica cy and safety of budesonide inhalation suspension in doses of 0.25 mg once daily, 0.25 mg twice daily, 0.5 mg twice daily, and 1.0 mg daily in infants and young children with persistent asthma. The retrospective analysis pres ented here compares the efficacy of treatment with the suspension administe red through a face mask or mouthpiece. All patients receiving budesonide in halation suspension via face mask or mouthpiece showed clinical improvement s in nighttime and daytime asthma symptoms as compared with administration of a placebo. The improvements were of similar magnitude as those observed in an analysis of all patients treated. Improvements in nighttime asthma sy mptoms were statistically significant with budesonide at 0.25 mg daily (p = 0.040), 0.25 mg twice daily (p = 0.008), and 0.5 mg twice daily (p = 0.046 ) delivered by face mask. In patients using mouthpieces, nighttime asthma s ymptoms improved significantly in the 0.25-mg twice-daily (p = 0.005) and 1 .0-mg daily (p = 0.035) groups. Patients receiving budesonide at 0.5 mg twi ce daily via a face mask improved significantly in daytime asthma symptoms (p = 0.009). The use of breakthrough medication was reduced in patients rec eiving budesonide via face masks or mouthpieces relative to placebo, and tr eatment was well tolerated in all study groups. This retrospective analysis suggests that nebulized budesonide inhalation suspension can be administer ed effectively by either face mask or mouthpiece to young children with per sistent asthma.