EFFICACY AND SAFETY OF BUDESONIDE INHALATION SUSPENSION (PULMICORT RESPULES) IN YOUNG-CHILDREN WITH INHALED STEROID-DEPENDENT, PERSISTENT ASTHMA

Background: Inhaled glucocorticosteroids are indicated for the treatme nt of persistent asthma: however, many young children are unable to ef fectively use currently available inhalers. Objective: We sought to ev aluate the efficacy and safety of 3 different tn icr daily doses of bu desonide 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 m g twice daily were administered by means of a jet nebulizer and air co mpressor system. Efficacy nas assessed by recording at home nighttime and day time asthma symptom scores, use of rescue medication, pulmonar y function tests, and treatment discontinuation because of worsening s ymptoms. 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, sympto m scores, and pulmonary function data were similar across treatment gr oups. All doses of budesonide inhalation suspension were superior to p lacebo in improving nighttime and daytime asthma symptom scores (P les s than or equal to .026), reducing use of breakthrough medication (P l ess than or equal to .032), and improving morning peak expiratory flow (P less than or equal to .030). The number of dropouts because of wor sening asthma was also significantly fewer in the budesonide groups (P less than or equal to .015), There were no differences between doses of budesonide, Adverse events and basal and adrenocorticotrophic hormo ne-stimulated cortisol responses were not different between budesonide and placebo groups. Conclusion: Budesonide inhalation suspension, 0.2 5 mg, 0.50 mg, and 1.0 mg twice daily, is an effective and safe treatm ent for young children with inhaled steroid-dependent, persistent asth ma.