Murphy KR, Fitzpatrick S, Cruz-Rivera M, et al. Pediatrics. 2003;112:e212–e219
Purpose of the Study.
To compare the effects of 2 nebulized antiinflammatory asthma medications on asthma control and caregiver quality of life.
Children 2 to 6 years of age, with mild/moderate persistent asthma, were studied.
This was a 52-week randomized trial in which the children received either budesonide inhalation suspension (0.5 mg once or twice daily) (N = 168) or cromolyn sodium nebulizer solution (20 mg 4 times daily) (N = 167) initially for 8 weeks, after which the dosage was adjusted at the discretion of the investigator. The Pediatric Asthma Caregiver’s Quality of Life Questionnaire, Compliance/Caregiver Satisfaction Questionnaire, and Modified Child Health Questionnaire-Parent Form 50 and Functional Status-II(R) questionnaires were administered at baseline and at weeks 8, 28, and 52. At the conclusion of the study, global evaluations of the simplicity of asthma management and child health care status were obtained from caregivers and physicians.
Improvements from baseline values in domain-specific (activities and emotional function) and total quality of life scores were greater at each time point (weeks 8, 28, and 52) for caregivers of patients treated with budesonide, compared with caregivers of patients treated with cromolyn sodium. Only the budesonide group met the criterion for a clinically important improvement (≥0.5-unit change) in all quality of life domains by week 8, which was maintained at weeks 28 and 52. Budesonide resulted in greater caregiver satisfaction, treatment convenience, ease of use, and compliance, compared with cromolyn sodium. Therefore, 90.7% of caregivers in the budesonide group were completely or very satisfied, compared with 53.4% in the cromolyn sodium group. More than one-half (54.6%) of caregivers in the budesonide group rated budesonide highly or very convenient, compared with 23% for cromolyn sodium; 77% rated budesonide extremely or very easy to use, compared with 47% for cromolyn. Adherence with daily medication regimens was reported for 76% of children in the budesonide group, compared with 57% in the cromolyn sodium group. Child health status showed improvements from baseline values for both groups at weeks 8, 28, and 52. There was a trend for these improvements to be superior in the budesonide group. In addition, budesonide was superior to cromolyn sodium in caregiver and physician global assessments.
Budesonide inhalation suspension improved the quality of life for caregivers of children with asthma. Caregivers of children treated with budesonide reported significantly fewer limitations in daily activities and emotional functioning, compared with caregivers of children treated with cromolyn sodium nebulizer solution. Children treated with budesonide inhalation suspension and cromolyn sodium experienced improvements in health status. Treatment with budesonide inhalation suspension resulted in significantly lower mean rates of asthma exacerbations, significantly longer times to first asthma exacerbation, significantly longer times to first additional use of chronic asthma therapy, and significant improvements in asthma symptom scores and breakthrough medication use, compared with cromolyn sodium therapy. Safety profiles were similar for the 2 treatment groups. Budesonide inhalation suspension was associated with significantly greater caregiver satisfaction, convenience, ease of use, and compliance, compared with cromolyn sodium nebulizer solution.
This was a nice study but the results are certainly not surprising. How many of us would have predicted that cromolyn would prove superior to an inhaled corticosteroid?