Abstract

Objective: To compare inhaled budesonide given daily or as-needed in mild persistent childhood asthma.

Patients, design and interventions: 176 children aged 5–10 years with newly detected asthma were randomized into three treatment groups: (1) continuous budesonide (400 µg twice daily for 1 month, 200 µg twice daily for Months 2–6, 100 µg twice daily for Months 7–18); (2) budesonide, identical treatment to Group 1 during Months 1–6, then budesonide for exacerbations as-needed for Months 7–18; and (3) disodium cromoglycate (DSCG) 10 mg three-times daily for Months 1–18. Exacerbations were treated with budesonide 400 µg twice daily for 2 weeks.

Main outcome measures: Lung function, the number of exacerbations and growth.

Results: Compared with DSCG the initial regular budesonide treatment resulted in a significantly better improvement of lung function, fewer exaxerbations and a small but significant decline in growth velocity. After 18 months, however, the lung function improvements did not differ between the groups. During Months 7-18 patients receiving continuous budesonide treatment had significantly fewer exacerbations (mean 0.97), compared with 1.69 in Group 2 and 1.58 in Group 3. The number of asthma free days did not differ between regular and intermittent budesonide treatment. Growth velocity was normalized during continuous low-dose budesonide and budesonide therapy given as needed. The latter was associated with catch-up growth.

Conclusions: Regular use of budesonide afforded better asthma control but more systemic effect than use of budesonide as needed. The dose of ICS could be reduced as soon as asthma is controlled. A proportion of children does not seem to need continuous ICS treatment.