Purpose of the Study
The purpose of the study was to evaluate the efficacy and safety of three different twice-daily doses of budesonide inhalation suspension in inhaled steroid-dependent asthmatic children.
There was a placebo group of 44 children, average age 80 months; the three dosing schedules for the budesonide included 0.25 mg bid, 47 children with an average age of 78 months; 0.50 mg bid, 42 children, average age 82 months; and 1.0 mg bid, 45 children, average age 81 months. The study was performed in 17 centers in the United States and represented administration of either placebo or specified dose of budesonide via jet nebulizer. The patients were required to have a forced expiratory volume in 1 second (FEV1) with an at least 50% of predicted normal value and a reversibility of at least 15% after a standard dose of inhaled bronchodilator. The study design was a randomized, double-blind, placebo-controlled parallel group study. The study lasted for 14 weeks.
Baseline demographics, symptom scores, and pulmonary function data were similar across the four treatment groups. All doses of budesonide inhalation suspension were superior to placebo in improving nighttime and daytime asthma symptom scores, reducing the use of breakthrough medication, and improving morning peak flow. The number of dropouts because of worsening asthma was also significantly fewer in the budesonide groups. There were no differences between doses of budesonide. Adverse events and basal and adrenocorticotropic hormone stimulated cortisol responses were not different between the budesonide and placebo groups.
Budesonide inhalation suspension at any of the three doses was an effective and safe treatment for young children with inhaled steroid-dependent persistent asthma.
This article allows for the discussion of several controversial points. One is the efficacy of inhaled corticosteroids as delivered by jet nebulizer versus by metered-dose inhaler with a device such as an aerochamber with mask. Although comparative trials are still lacking, there is literature to suggest that inhaled steroids, both budesonide and fluticasone, can be delivered in a clinically effective manner by using a metered-dose inhaler with an aerochamber and mask. Issue two is the ongoing discussion regarding the relative efficacy of different concentrations of inhaled corticosteroids. This study had a very interesting finding that the positive outcomes did not appear to be significantly different between groups treated with budesonide regardless of the concentration. This too echoes previous papers that suggested that often the increase in dose of an inhaled corticosteroid does not result in a marked improvement in function. This becomes extremely important when one considers the potential side effects of these medications. The third interesting facet of this study is the fact that there appeared to be no change in baseline adrenal function, or the ability to respond to stimulation. This is encouraging in this ongoing discussion of the relative safety of these compounds. The study, performed for only 14 weeks, does not allow for any conclusions concerning the potential inhibition of growth at any of the tested concentration. This represents a very well conducted study that adds to the literature on how these various medications can be delivered, the clinical significance of different concentrations, and their relative safety.