Daily Versus As-Needed Inhaled Corticosteroid for Mild Persistent Asthma (The Helsinki Early Intervention Childhood Asthma Study)

Turpeinen M, Nikander K, Pelkonen AS, et al. Arch Dis Child. 2008;93(8):654–659

PURPOSE OF THE STUDY. To compare the effect on mild persistent asthma of inhaled budesonide given daily or as needed.

METHODS. A total of 176 children 5 to 10 years of age with newly diagnosed asthma were randomly assigned to 3 treatment groups, (1) continuous budesonide dry powder inhaler, given at 400 mg twice daily for 1 month, 200 mg twice daily for months 2 to 6, and 100 mg twice daily for months 7 to 18; (2) budesonide treatment identical to group 1 for months 1 to 6 and then placebo for months 7 to 18; or (3) cromolyn metered dose inhaler at 10 mg 3 times daily for months 1 to 18 (control group). All patients were given rescue medication (terbutaline, 0.25 mg per dose) as needed. For all groups, during exacerbations of asthma, study medication was replaced by budesonide at 400 mg twice daily for 2 weeks. Outcome measures were lung function, number of exacerbations, number of asthma-free days, and growth.

RESULTS. Compared with cromolyn (group 3), the initial regular budesonide treatment (groups 1 and 2) resulted in significantly improved lung function (increase in forced expiratory volume in 1 second of 9.6% vs 5.9%), fewer exacerbations per patient (0.32 vs 1.24 exacerbations), more asthma-free days (increase of 20.1% vs 4.1%), and a small but significant decrease in growth velocity. After 18 months, the lung function improvements did not differ between the groups. During months 7 to 18, patients receiving continuous budesonide treatment had fewer exacerbations per patient (0.97 exacerbations, compared with 1.69 exacerbations in group 2 and 1.58 exacerbations in group 3). Three patients in group 1 and 9 patients in group 2 were withdrawn because of asthma deterioration after 6 months of treatment. The number of asthma-free days did not differ between groups 1 and 2 but remained better than in group 3. Growth velocity was normalized in groups 1 and 2.

CONCLUSIONS. Regular use of budesonide afforded better asthma control but had a more systemic effect than did as-needed use of budesonide.

REVIEWER COMMENTS. It is not a surprise that the inhaled corticosteroids achieved better asthma control than did cromolyn and are the preferred medications. The question addressed by this study is whether inhaled corticosteroids can be used as needed versus continuously. Although these 2 approaches did not differ in lung function or number of asthma-free days, the continuous-treatment group had significantly fewer exacerbations. An accompanying editorial (Pedersen S. Arch Dis Child. 2008;93[8]:644–645) asks, “Do the benefits of daily inhaled steroid treatment of mild asthma outweigh the risks?” and answers in the affirmative, noting that regular use is safe (6 of 7 studies found no long-term effects on growth), as well as more effective and less expensive than any other treatment.

• Copyright © 2009 by the American Academy of Pediatrics