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Randomized Controlled Trial
. 2008 Aug;93(8):654-9.
doi: 10.1136/adc.2007.116632. Epub 2007 Jul 18.

Daily versus as-needed inhaled corticosteroid for mild persistent asthma (The Helsinki early intervention childhood asthma study)

M Turpeinen  1 , K Nikander, A S Pelkonen, P Syvänen, R Sorva, H Raitio, P Malmberg, K Juntunen-Backman, T Haahtela
Affiliations
Randomized Controlled Trial

Daily versus as-needed inhaled corticosteroid for mild persistent asthma (The Helsinki early intervention childhood asthma study)

M Turpeinen et al. Arch Dis Child. 2008 Aug.

Abstract

Objective: To compare the effect of inhaled budesonide given daily or as-needed on mild persistent childhood asthma. Patients, design and

Interventions: 176 children aged 5-10 years with newly detected asthma were randomly assigned to three treatment groups: (1) continuous budesonide (400 microg twice daily for 1 month, 200 microg twice daily for months 2-6, 100 microg 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 microg 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 improved lung function, fewer exacerbations 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 normalised 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 had a more systemic effect than did use of budesonide as needed. The dose of ICS could be reduced as soon as asthma is controlled. Some children do not seem to need continuous ICS treatment.

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Conflict of interest statement

Competing interests: None.

Figures

Figure 1
Figure 1. Study design. The daily dose of budesonide was divided into two doses, DSCG into three doses.
Figure 2
Figure 2. The flow of the participants through the trial.
Figure 3
Figure 3. Kaplan–Meier plot of the time to first exacerbation for the continuous budesonide (O, n = 57), budesonide/placebo (□, n = 58) and disodium cromoglycate (Δ, n = 60) treatment groups during the 18-month study. The median time to the first exacerbation was significantly longer for both the continuous budesonide (344 days) and the budesonide/placebo (268 days) groups compared with the DSCG group (78 days) (p<0.001 for each). The vertical line indicates the time point (180 days) when budesonide treatment was changed to the low-dose regimen or to placebo. After 180 days, the median time to the next exacerbation was 233 days for the continuous budesonide group, 138 days for the budesonide/placebo group and 131 days for the DSCG group (continuous budesonide and DSCG; p = 0.03).
Figure 4
Figure 4. Mean change in standing height (SDS) over the 18-month study period for the continuous budesonide (◊, n = 50), budesonide/placebo (□, n = 45) and disodium cromoglycate (DSCG) (Δ, n = 43) treatment groups. 1–6 months, both budesonide groups versus DSCG, p<0.001; 7–18 months, continuous budesonide group versus budesonide/placebo group, p = 0.016. Note the fast height velocity during months 7–18 in the budesonide/placebo group.
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