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.

Background: Inhaled glucocorticosteroids are indicated for the treatment of persistent asthma; however, many young children are unable to effectively use currently available inhalers. Objective: We sought to evaluate the efficacy and safety of 3 different twice daily doses of budesonide inhalation suspension (Pulmicort Respules) in inhaled steroid–dependent asthmatic children. Methods: This was a 12-week, randomized, double-blind, placebo-controlled, parallel-group study involving 178 children (age range, 4 to 8 years) at 17 centers in the United States. Budesonide inhalation suspension doses of 0.25 mg, 0.50 mg, or 1.0 mg twice daily were administered by means of a jet nebulizer and air compressor system. Efficacy was assessed by recording at home nighttime and daytime asthma symptom scores, use of rescue medication, pulmonary function tests, and treatment discontinuation because of worsening symptoms. Safety was assessed by reported adverse events and changes in baseline and adrenocorticotrophic hormone–stimulated plasma cortisol levels in a subset of patients. Results: Baseline demographics, symptom scores, and pulmonary function data were similar across treatment groups. All doses of budesonide inhalation suspension were superior to placebo in improving nighttime and daytime asthma symptom scores (P ≤ .026), reducing use of breakthrough medication (P ≤ .032), and improving morning peak expiratory flow (P ≤ .030). The number of dropouts because of worsening asthma was also significantly fewer in the budesonide groups (P ≤ .015). There were no differences between doses of budesonide. Adverse events and basal and adrenocorticotrophic hormone–stimulated cortisol responses were not different between budesonide and placebo groups. Conclusion: Budesonide inhalation suspension, 0.25 mg, 0.50 mg, and 1.0 mg twice daily, is an effective and safe treatment for young children with inhaled steroid–dependent, persistent asthma. (J Allergy Clin Immunol 1998;102:789-96.)