Am. J. Respir. Crit. Care Med., Volume 162, Number 2, August 2000, 593-598

Comparable Efficacy of Administration with Face Mask or Mouthpiece of Nebulized Budesonide Inhalation Suspension for Infants and Young Children with Persistent Asthma

MICHAEL MELLON, JEFFREY LEFLEIN, KAREN WALTON-BOWEN, MARIO CRUZ-RIVERA, SHERAHE FITZPATRICK, and JOSEPH A. SMITH

Allergy Department, Kaiser Permanente Medical Offices, San Diego, California; Allergy and Immunology Associates of Ann Arbor, Ypsilanti, Michigan; and AstraZeneca, Wayne, Pennsylvania

A randomized, double-blind, placebo-controlled, parallel-group study including 481 children at 37 centers in the United States demonstrated the efficacy 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 presented here compares the efficacy of treatment with the suspension administered through a face mask or mouthpiece. All patients receiving budesonide inhalation suspension via face mask or mouthpiece showed clinical improvements 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 symptoms 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 symptoms 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 twice daily via a face mask improved significantly in daytime asthma symptoms (p = 0.009). The use of breakthrough medication was reduced in patients receiving budesonide via face masks or mouthpieces relative to placebo, and treatment was well tolerated in all study groups. This retrospective analysis suggests that nebulized budesonide inhalation suspension can be administered effectively by either face mask or mouthpiece to young children with persistent asthma.

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