Mild asthma: steroid rescue therapy an option.
"Assessed from a risk-benefit point of view, our data suggest that, in children with mild persistent asthma, use of rescue inhaled corticosteroid could be an effective step-down alternative to discontinuation of such treatment after asthma control is achieved," Dr. Fernando D. Martinez of the Arizona Respiratory Center and the University of Tucson (Ariz.), and his associates said.
This approach "could also be an alternative, step 2 therapeutic approach for mild persistent asthma in individuals who have not previously received a course of daily corticosteroid treatment," they added, although they noted that the 44-month randomized, double-blind study was not designed to address this issue (Lancet 2011;377:650-7).
The TREXA (Treating Children to Prevent Exacerbations of Asthma) study was conducted to determine whether discontinuing treatment with daily inhaled corticosteroids (ICS) in children with well controlled mild persistent asthma increased the risk of exacerbations, and whether combining beclomethasone and albuterol as rescue therapy, with or without daily bedomethasone, was more protective against asthma exacerbations than was an albuterol-only rescue strategy.
In the study, 288 children and adolescents aged 5-18 years from five U.S. clinical centers, with mild persistent asthma during the previous 2 years, were randomized to one of four treatment groups:
* Beclomethasone twice daffy, with beclomethasone plus albuterol as rescue (combined group).
* Beclomethasone twice daily, with placebo plus albuterol as rescue (daffy beclomethasone group).
* Placebo twice daffy, with beclomethasone plus albuterol as rescue (rescue beclomethasone group).
* Placebo twice daffy, with placebo plus albuterol as rescue (placebo group).
Twice-daily beclomethasone treatment was one puff (40 mcg per puff) in the morning and evening; rescue beclomethasone treatment was two puffs of beclomethasone (80 mcg) for every two puffs of albuterol (180 mcg) needed for relief of symptoms. The primary outcome was the time to first exacerbation requiring treatment with oral corticosteroids.
Among those in the placebo group, who received only albuterol as rescue, the exacerbation rate was 49%, compared with 31% in the combined group, 28% in the daffy group, and 35% in the rescue group. "Compared with the placebo group, the hazard ratios for asthma exacerbations were significantly lower in the daffy beclomethasone group and the combined group, but the difference was not significant in the rescue beclomethasone group," they found.
The children in the two groups using daffy beclomethasone also showed signs of less linear growth, a secondary end point: Children in these two groups grew a mean of 1.1 cm less than did those in the placebo group, a statistically significant difference. But the children in the rescue beclomethasone group (who received less than a quarter of the total daily ICS dose that the children in the combined and daffy beclomethasone groups received) grew a mean of 0.3 cm less than did those in the placebo group, which was not a significant difference.
There were two adverse events considered severe in the study: a case of viral meningitis in the daffy beclomethasone group and a case of bronchitis in the combined group.
Noting that children with mild persistent asthma should not be treated with rescue albuterol alone and that daffy ICS is the most effective treatment to prevent exacerbations in this age group, the authors said that "our data suggest that inhaled corticosteroids used as rescue together with albuterol show benefits over rescue albuterol alone and avoid the growth effects associated with use of daily inhaled corticosteroids."
They added that to their knowledge, the study was the first to look at the use of ICS with albuterol as rescue therapy in school-aged children.
These results "have potentially important implications for the management of asthma," Dr. William Checkley wrote in an accompanying editorial (Lancet 2011 377:614-6).
He noted that the British Thoracic Society and the National Heart, Lung, and Blood Institute's National Asthma Education and Prevention Program guidelines recommend daily ICS use as initial and step-up treatment for persistent asthma, and "step-down is possible if asthma symptoms are well controlled for at least 3 months." The results of this study, however, "suggest that step-down from daily inhaled corticosteroids to such treatment as rescue in combination with rescue short-acting beta-agonists could be a reasonable step-down strategy for patients with mild persistent asthma," wrote Dr. Checkley of the pulmonary and critical care division at Johns Hopkins University, Baltimore. This strategy would reduce the cumulative exposure to ICS "and obviate concerns about compliance with long-term controller treatment," he added, noting that more studies are needed.
The study was funded by the NHLBI. Bedomethasone and the placebo inhalers were provided by Teva Pharmaceutical Industries, the manufacturer of a generic formulation of beclomethasone. Of the 20 coauthors, 12, including lead author Dr. Martinez, reported having been a board member and/or having received consulting fees and/or honoraria; grant support from various pharmaceutical companies, including AstraZeneca, GlaxoSmithKline, MedImmune, and Merck was reported to be pending for these 12 authors as well. The remaining authors reported that they had no relevant financial disclosures.
BY ELIZABETH MECHCATIE
FROM THE LANCET
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|Title Annotation:||PULMONARY MEDICINE|
|Publication:||Family Practice News|
|Date:||Mar 1, 2011|
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