More trials urged to determine optimal doses of ICS for children with persistent asthma

Zhang L. Pediatrics. 2010; DOI: 10.1542/peds.2010-1223.

Moderate doses of inhaled corticosteroids (ICS) may not provide additional benefit to children with mild- to moderate-persistent asthma compared with lower doses, according to the results of a meta-analysis reported online this week.

Linjie Zhang, MD, PhD, and colleagues from the Maternal and Child Health Unit, Faculty of Medicine, Federal University of Rio Grande in Rio Grande, Brazil, searched 60 years of MEDLINE studies for randomized controlled trials that compared two or more different ICS doses in children aged 3 to 18 years with persistent asthma.

The researchers included 14 randomized controlled trials that included 5,768 asthmatic children. Low doses were slightly but statistically significantly more effective in improving forced expiratory volume in 1 second among children with mild to moderate asthma, based on the mean difference from six trials. However, other efficacy outcomes were not different between the two doses, and there was no evidence of a dose-response relationship at low to moderate doses, the researchers said, adding that additional randomized controlled trials are needed to clarify the results.

The researchers noted that no uniformity among the trials might have limited the conclusions.

“The results of this review reveal a significant gap in understanding the dose-response relationship of ICS in children with persistent asthma, which makes it impossible to recommend the optimal doses of ICS for these patients,” the researchers concluded. “Additional high-quality randomized trials are needed to compare efficacy and safety of different doses of ICS in children with persistent asthma, especially higher dose ranges in patients with more severe asthma.”

The authors reviewed 60 years of clinical trials in children with asthma and came to the same conclusion that myself and many asthma specialists have reached. We do not know what dose or even which ICS or device is best for particular patients.

In fact, the NAEPP EPR3 and prior reports have wrestled with this dilemma and have taken a good guess at ICS doses to use based on asthma severity.

We also don't know how long and which measure we should use to fully evaluate the effect of ICS. Maybe it’s about time that a long-term appropriate study be done to answer this question.

— Gary Rachelefsky, MD
Infectious Diseases in Children Editorial Board

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