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June 2005 SAN ANTONIO — Inhaled steroids improved asthma symptoms in high-risk toddlers, but the improvements ceased when controller therapy was stopped, according to preliminary results of the Prevention of Early Asthma in Kids (PEAK) study, presented here at the American Academy of Asthma, Allergy and Immunology annual meeting. The PEAK study investigated whether inhaled corticosteroids could alter the natural history of asthma when initiated in preschoolers at high risk for asthma. Early results showed that asthma symptoms and exacerbations were fewer and lung function improved, but only while the children were on therapy, according to Theresa Guilbert, MD, an assistant professor at the Arizona Respiratory Center at the University of Arizona School of Medicine in Tucson. Guilbert is a lead investigator of the study and presented the results for the Childhood Asthma Research and Education Network, funded by the National Heart, Lung and Blood Institute. The PEAK investigators are preparing final results for publication in a peer-reviewed journal. In the multicenter, double-blind PEAK trial, researchers enrolled 285 2- and 3-year-olds that were at risk for developing asthma. They were randomized to either low-dose inhaled corticosteroids (143 children) or placebo (142 children) for two years and then were observed one year without medication. Children were included if they had a positive asthma predictive index, had not been premature, had no systemic illnesses apart from allergies and asthma. Children were determined high risk if they had at least four episodes of wheeze in the past year (one confirmed by a physician) plus other criteria, such as family history or parental history of asthma, atopic dermatitis, and aeroallergen sensitization or wheezing unrelated to infection, among other criteria. If the child experienced symptoms during the study, therapy was stepped up. If a child had at least one month of persistent symptoms or required four courses of oral steroids in a year, they received montelukast (Singular, Merck). If they required hospitalizations or symptoms that were not controlled on montelukast, they were given fluticasone (Flovent, GlaxoSmithKline). Other asthma medications were started based on physician discretion. Ten percent of children were lost to follow-up during the treatment phase, and 12% by the end of the observation period. Baseline characteristics were similar between the study groups. “The inhaled fluticasone appeared to significantly increase the proportion of episode-free days compared with placebo while the participants were on treatment, but the difference disappeared quickly after they are taken off study medication,” Guilbert said during her presentation.
Based on the early findings, the inhaled corticosteroid group did not have more episode-free days during the observation period and there was no significant difference between the two study groups when they required supplemental asthma medication. There were no differences seen between groups for the number of exacerbations requiring systemic corticosteroids, between health care use, no differences in supplementary asthma medication, and lung function, determined by oscillometry measurements. The average number of days of supplemental inhaled corticosteroid use was 26% less in the inhaled corticosteroid group, but this difference was temporary, she said. There was also no significant difference in adherence, completed visits, treatment dropouts, treatment failures or serious adverse events between study groups. “By the end of treatment, the treatment group has maintained 95% episode-free days, but the placebo group has dropped to 89%,” Guilbert reported. “By the end of the observation, both groups are about 85%, showing an increase of symptoms across time.” While on treatment, the fluticasone group had significantly fewer asthma exacerbations compared with placebo. Looking at supplementary controller group, the inhaled corticosteroid group had 53% less supplementary inhaled corticosteroid use and supplementary montelukast use. The investigators conclude that inhaled corticosteroids modulate airway inflammation similar to adults, but that the mechanisms that determine the progression of disease may be different than those that determine symptoms during acute and persistent asthma. For more information: |
