Despite being the traditional practice, increasing inhaled controller therapy doses during yellow-zone episodes does not stop asthma exacerbations.
Daniel J. Jackson, MD
While it is common practice to increase doses of inhaled glucocorticoid controller therapies when early signs of asthma control loss are observed, it appears the custom may be in vain.
In a presentation at the 2018 American Academy of Allergy, Asthma, and Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in Orlando, Florida, data from a study led by Daniel J. Jackson, MD, an associate professor of pediatrics at the University of Wisconsin School of Medicine and Public Health, in Madison, revealed that children with mild-to-moderate persistent asthma did not benefit from a quintupled dose of their inhaled controller therapy.
"These findings suggest that a short-term increase to high-dose inhaled steroids should not be routinely included in asthma treatment plans for children with mild-moderate asthma who are regularly using low-dose inhaled corticosteroids," Jackson, a childhood asthma expert, said in a statement. "Low-dose inhaled steroids remain the cornerstone of daily treatment in affected children."
The population studied was a cohort of 254 children with persistent asthma, aged 5 to 11 years, that had experienced at least 1 exacerbation that was treated with systemic glucocorticoids in the past year. Each patient received 48 weeks of treatment with low maintenance doses—44 µg per inhalation, twice daily—of fluticasone propionate, and was randomized to receive, upon the early signs of uncontrolled asthma (defined as “yellow zone”), either the same dose (low-dose group) or a quintupled dose of 220 µg per inhalation twice daily (high-dose group).
Rates of asthma exacerbations were not significantly different between the 2 groups, with the high-dose group averaging 0.48 per year and the low-dose group averaging 0.37 per year (relative rate, 1.3; 95% CI, 0.8—2.1; P = .30). Additionally, the time to first exacerbation, rates of treatment failure, symptom scores, and albuterol use also did not differ significantly between the high- and low-dose groups.
In total, and somewhat expectedly, glucocorticoid exposure was 16% higher in the high-dose group. Linear growth was —0.23 cm less per year for the high-dose group (P = .06).
"This study allows caregivers to make informed decisions about how to treat their young patients with asthma," James Kiley, PhD, the director of the National Heart, Lung, and Blood Institute's Division of Lung Diseases, which funded the study, said in statement. "Trials like this can be used in the development of treatment guidelines for children with asthma."
The authors acknowledged that there were fewer yellow-zone episodes observed than anticipated, as well as 40% fewer exacerbations than expected, although the reasons for this were reportedly unclear. This, Jackson and colleagues admitted, lowered the power of the trial to detect a difference between groups.
To date, only 1 randomized clinical trial involving pediatric patients and budesonide-formoterol has shown benefits for the increase in inhaled glucocorticoids during yellow-zone episodes, according to the authors.
The study, “Quintupling Inhaled Glucocorticoids to Prevent Childhood Asthma Exacerbations,” was published simultaneously in the New England Journal of Medicine.
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