Intermittent inhaled corticosteroids effective for childhood asthma

This study shows a new way to treat a common problem, with less side effects.
From Daily POEM (Patient Oriented Evidence that Matters) part of Essential Evidence Plus service, which analyzes the medical literature to identify studies that really matter.

Clinical Question
For young children with frequent episodes of wheezing, is intermittent use of an inhaled corticosteroid as effective as daily use?
Bottom Line
For young children with frequent wheezing recurrences but relatively few symptoms between exacerbations, intermittent high-dose inhaled budesonide (1 mg twice daily for 1 week during exacerbations) is just as effective as daily moderate-dose budesonide. (LOE = 1b)
Reference
Zeiger RS, Mauger D, Bacharier LB, et al, for the CARE Network of the National Heart, Lung, and Blood Institute. Daily or intermittent budesonide in preschool children with recurrent wheezing. N Engl J Med 2011;365(21):1990-2001.
Study Design
Randomized controlled trial (double-blinded)

Funding

Government

Setting
Outpatient (any)

Allocation
Uncertain
Synopsis
Daily use of inhaled corticosteroids can affect height growth, and adherence is a challenge, especially for young children. These researchers recruited children aged 12 months to 53 months who had least 4 episodes of wheezing during the previous year, had at least 1 exacerbation that required the use of systemic steroids and urgent or emergent care, but did not use albuterol more than 3 days a week and had less than 2 nights of awakening because of symptoms. Thus, these children had frequent, sometimes serious, exacerbations but did not have many symptoms between exacerbations. The study began with 450 patients, of whom 172 were excluded, mostly because of excessive asthma symptoms during the placebo run-in period. A total of 278 children were randomized to receive daily budesonide inhalation (0.5 mg once each evening) or intermittent high-dose budesonide inhalation taken during exacerbations (1 mg twice daily). A double-dummy approach was used with placebo inhalers for daily or intermittent use (that is, all patients used an inhaler nightly and all used an inhaler during exacerbations, but in each case half were given the active drug and half were given placebo). Groups were balanced at the start of the study, and analysis was by intention to treat (213 kids completed the study). Approximately 70% of the children had a physician diagnosis of asthma, and 19% had been hospitalized in the previous year. Most parents had a personal history of asthma and were thus able to recognize symptoms. Patients were followed up for 1 to 2 years, and during that time there were a few more dropouts in the daily treatment group due to caregiver dissatisfaction, physician initiated withdrawal, side effects, or treatment failure (12 vs 3 in the intermittent group). There was no difference between groups in the number of exacerbations per patient-year (about 1 per year in both groups). There were no differences in other measures of asthma severity or respiratory tract symptoms. Children in the intermittent-dosing group received approximately 100 mg less steroid per year.
POEM written by:  Mark H. Ebell, MD, MS Associate Professor University of Georgia.

Robert Moore, MD, MPH

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