Efficacy and safety of budesonide inhalation suspension (Pulmicort Respules) in young children with inhaled steroid–dependent, persistent asthma

Abstract

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.)