Chen YZ, Busse WW, Pedersen S, Tan W, Lamm CJ, O’Byrne PM. Pediatr Allergy Immunol. 2006;17:7–13
PURPOSE OF THE STUDY. To determine the long-term efficacy of regular inhaled low-dose budesonide in children aged <11 years with recent-onset mild-persistent asthma.
STUDY POPULATION. Children aged 5 to 10 years with current symptoms of mild-persistent asthma during the 3 months preceding trial entry. Patients had no symptoms for >2 years before study entry and had received neither inhaled corticosteroids (ICSs) for ≥30 days nor depot corticosteroid injection in the previous year.
METHODS. Patients were randomly assigned to receive once-daily budesonide 200 μg (1000 children) or placebo (974 children). Patients were followed at weeks 6 and 12 and then subsequently every 3 months for a 3-year period. Patients and their caregivers kept a record of asthma symptoms between visits. At each visit, spirometry was performed, and data were collected on medication compliance and asthma control. The primary end point was the time to the first severe asthma-related event (SARE) or introduction of corticosteroid treatment other than the study medication.
RESULTS. There was a 40% relative-risk reduction of SAREs in the treatment group over the 3-year study visit. Fewer children in the budesonide group required treatment with other corticosteroids as compared with those in the placebo group (12.3% vs 22.7%). There was a trend toward decreased β2-agonist use, decreased systemic corticosteroid use, and improved lung function in the children in the treatment arm.
CONCLUSIONS. The early addition of once-daily budesonide treatment in young children with mild-persistent asthma improves asthma control and lung function and decreases the risk of SAREs.
REVIEWER COMMENTS. Early asthma intervention in children is a topic of much debate, particularly in the very young with mild symptoms. Oftentimes, caregivers are faced with the difficult task of deciding on the right time to initiate an ICS, and the decision may be delayed until a serious event such as hospitalization occurs. This study demonstrates the benefits of using an ICS as early intervention in children <11 years of age to improve lung function and decrease the risks of serious and potentially life-threatening asthma exacerbations. Unlike previous studies in pediatric populations with mild asthma, researchers with this study enrolled patients with relatively newly diagnosed asthma, perhaps before the onset of chronic irreversible inflammatory changes such as basement-membrane thickening. These findings support early intervention to improve lung function and to potentially prevent loss of lung function in hopes of improving long-term outcomes.
- Copyright © 2007 by the American Academy of Pediatrics