Long-term effects of budesonide or nedocromil in children with asthma

Background: Antiinflammatory therapies, such as inhaled corticosteroids or nedocromil, are recommended for children with asthma, although there is lim ited information on their long-term use. Methods: We randomly assigned 1041 children from 5 through 12 years of age with mild-to-moderate asthma to receive 200 microg of budesonide (311 child ren), 8 mg of nedocromil (312 children), or placebo (418 children) twice da ily. We treated the participants for four to six years. All children used a lbuterol for asthma symptoms. Results: There was no significant difference between either treatment and p lacebo in the primary outcome, the degree of change in the forced expirator y volume in one second (FEV(sub 1), expressed as a percentage of the predic ted value) after the administration of a bronchodilator. As compared with t he children assigned to placebo, the children assigned to receive budesonid e had a significantly smaller decline in the ratio of FEV(sub 1) to forced vital capacity (FVC, expressed as a percentage) before the administration o f a bronchodilator (decline in FEV(sub 1):FVC, 0.2 percent vs. 1.8 percent) . The children given budesonide also had lower airway responsiveness to met hacholine, fewer hospitalizations (2.5 vs. 4.4 per 100 person-years), fewer urgent visits to a caregiver (12 vs. 22 per 100 person-years), greater red uction in the need for albuterol for symptoms, fewer courses of prednisone, and a smaller percentage of days on which additional asthma medications we re needed. As compared with placebo, nedocromil significantly reduced urgen t care visits (16 vs. 22 per 100 person-years) and courses of prednisone. T he mean increase in height in the budesonide group was 1.1 cm less than in the placebo group (22.7 vs. 23.8 cm, P=0.005); this difference was evident mostly within the first year. The height increase was similar in the nedocr omil and placebo groups. Conclusions: In children with mild-to-moderate asthma, neither budesonide n or nedocromil is better than placebo in terms of lung function, but inhaled budesonide improves airway responsiveness and provides better control of a sthma than placebo or nedocromil. The side effects of budesonide are limite d to a small, transient reduction in growth velocity. (N Engl J Med 2000;34 3:1054-63.) (C) 2000, Massachusetts Medical Society.