A University of Arizona national childhood asthma study suggests a new treatment regimen that decreases the risk of exacerbations in children with controlled asthma more effectively than daily inhaled corticosteroids.
To prevent asthma flare-ups, current recommendations suggest the daily use of inhaled corticosteroids (in the morning and evening). Corticosteroids are steroid hormone anti-inflammatory drugs used to control asthma and have a risk assessment associated with growth retardation in children.
The new research published in The Lancet shows that while the current recommendations remain the most effective way to prevent asthma exacerbations, children could instead use rescue therapy – the use of an inhaler only when their symptoms arise.
Dr. Fernando D. Martinez, Regents Professor and director of both the UA College of Medicine's Arizona Respiratory Center and of the BIO5 Institute, and colleagues from throughout the U.S. conducted the 44-week study.
"Our research suggests that use of rescue inhaled corticosteroid could be an effective step-down alternative to discontinuation of such treatment after asthma control is achieved," Martinez said.
This new approach, Martinez said, could avoid growth retardation and the need to use daily medication in children with mild persistent asthma, a modality of treatment that is often resisted and not followed by parents and children.
In the study, 288 children were assigned to one of four treatment groups to look at the relative efficacy of daily treatment and rescue therapy.
Participants were assigned to:
- A combined group of twice daily beclomethasone inhaler with beclomethasone plus albuterol inhaler as a rescue (71 patients);
- A daily group with twice daily beclomethasone inhaler with placebo plus albuterol inhaler as a rescue (72 patients);
- A rescue group of twice daily placebo with beclomethasone inhaler plus albuterol inhaler as a rescue (71 patients);
- A placebo group with twice daily placebo and placebo plus albuterol inhaler as a rescue (74 patients).
(When the beclomethasone inhaler or placebo was used as rescue, two puffs were used every time two puffs of albuterol were needed.)
The researchers found that, compared with the placebo group in which frequency of exacerbations was 49 percent, frequency was lower in the combined group at 31 percent, the daily group at 28 percent and the rescue group at 35 percent, with the combined and rescue result groups with borderline statistical significance.
Frequency of treatment failure was 23 percent in the placebo group, compared with 6 percent in the combined group, 3 percent in the daily group and 8 to 5 percent in the rescue group.
Martinez's team found that the use of a rescue beclomethasone inhaler can lower the risk of exacerbations and treatment failures, but to a lesser degree than daily use of a beclomethasone inhaler does.
"It is possible that this new treatment strategy could also be an alternative therapeutic approach for mild persistent asthma even in individuals who have not previously received a course of daily corticosteroid treatment, but our study was not designed to specifically address this issue," Martinez said.
He added, "the research could mean savings for the health-care system that would be substantial, because children on the two arms in which beclomethasone was added to albuterol as rescue, used one third of the total inhaled corticosteroid dose used by children on the two arms that used daily beclomethasone – with none of the significant growth effects observed in the latter."
Dr. William Checkley of the Division of Pulmonary and Critical Care in the Department of Medicine at Johns Hopkins University said that current U.S. and UK guidelines recommend daily use of inhaled corticosteroids as both initial and step-up treatment for persistent asthma, with step down only recommended after three months of controlled symptoms.
Said Checkley in a linked comment of the study: "The results of this trial, however, suggest that step-down from daily inhaled corticosteroids to such treatment as rescue in combination with rescue short-acting β agonists could be an effective step-down strategy for patients with mild persistent asthma."