Bisgaard H, Hermansen MN, Loland L, Halkjaer LB, Buchvald F. N Engl J Med. 2006;354:1998–2005
PURPOSE OF THE STUDY. To determine the effectiveness of inhaled corticosteroid (ICS) in the treatment of wheezing in infants and if early ICS treatment will delay or prevent progression to persistent asthma.
STUDY POPULATION. Pregnant women (N = 798) with the diagnosis of asthma were enrolled onto a cohort study in Denmark. There were 411 newborns enrolled by 1 month of age.
METHODS. The patients were randomly assigned to ICS or placebo with their first episode of wheezing at a median of 10.7 months. Treatment with budesonide 400 μg per day with a spacer or placebo with spacer was begun after the third day of the first wheezing episode and continued for at least 2 weeks. Terbutaline with the same delivery system was provided for as-needed use. Symptoms and β-agonist use were recorded daily for the 3 years of the study. One-hour study visits were conducted every 6 months. Nasal aspirates for viral culture and infant lung-function tests were monitored.
RESULTS. A total of 294 infants had at least 1 treatment with a total of 1661 episodes (577 episodes were not verified by an investigator). During the entire study, 83% of the ICS and 82% of the placebo days were symptom free. Twenty-four percent of the patients who received ICS and 21% who received placebo developed persistent symptoms. A respiratory virus was isolated in 369 (63%) of 583 episodes, but there was no relation to treatment outcome. Over the 3 years of the study, growth and bone mineral density (ultrasound technique) were not different in the groups.
CONCLUSIONS. Early intervention with ICS did not effect the duration of acute illnesses or progression to persistent disease.
REVIEWER COMMENTS. The results of this very important study were confounded by the effect of delaying 3 days to initiate therapy, the unclear efficacy of the delivery system, and that 40% of the events were not confirmed by the investigators.
- Copyright © 2007 by the American Academy of Pediatrics