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

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 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 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.

Inhaled Corticosteroids in Lung Diseases

“…The issue of improving compliance with once-daily administration of the ICSs remains to be evaluated in controlled clinical trials. In patients with mild or intermittent asthma, the use of ICSs as needed with rescue bronchodilator or intermittently at high doses for a prescribed duration (5-10 d) has been investigated in pediatric and adult populations (30)(31)(32)(33)(34)(35). These studies have been inconsistent and confirm greater efficacy of daily use of ICSs for controlling the impairment domain and mixed effects on preventing exacerbations requiring oral corticosteroids (30)(31)(32)(33)(34)(35).…”

“…In patients with mild or intermittent asthma, the use of ICSs as needed with rescue bronchodilator or intermittently at high doses for a prescribed duration (5-10 d) has been investigated in pediatric and adult populations (30)(31)(32)(33)(34)(35). These studies have been inconsistent and confirm greater efficacy of daily use of ICSs for controlling the impairment domain and mixed effects on preventing exacerbations requiring oral corticosteroids (30)(31)(32)(33)(34)(35). Although the combination BUD with the long-acting b 2 agonist (LABA) formoterol in a single inhaler has been approved in Europe and other countries for maintenance and reliever therapy, it has not been approved for this use in the United States, and recently concerns have been expressed that patients receiving this therapy are not well controlled and may have inadequately treated airways inflammation (30).…”

Skin Thickness in Children Treated With Daily or Periodical Inhaled Budesonide for Mild Persistent Asthma. The Helsinki Early Intervention Childhood Asthma Study

“…Children aged 5-10 y with newly detected asthma participated in a partially double-blind, randomized, parallel-group, and single-center 18-mo study (8). Children with chronic diseases other than asthma that could influence the performance of the study or interpretation of study results were excluded, as were children with atopic dermatitis of moderate or severe grade (extent of dermatitis Ͼ15% of body surface area).…”

“…This dosing of DSCG was based on the Pediatric Consensus Statement (9). Exacerbations in all three groups were treated with budesonide 400 g twice daily for a 2-wk period (8). This means that children in the budesonide/ placebo group received periodic treatment with budesonide during months 7-18.…”

Intranasal Triamcinolone and Growth Velocity

“…25 A similar observation of accelerated growth at follow-up was seen in previous asthma studies. 26,27 In this study, GV at follow-up reached pretreatment levels in the TAA-AQ group and, in fact, was numerically higher than that in the placebo group.…”