Study Helps Guide Treatment Choices for Childhood Asthma
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Study Helps Guide Treatment Choices for Childhood Asthma

BETHESDA, Md -- March 2, 2010 -- A new study has found the addition of long-acting beta-agonist therapy to be the most effective of 3step-up, or supplemental, treatments for children whose asthma is not well controlled on low doses of inhaled corticosteroids alone.

Researchers also identified patient characteristics, such as race, that can help predict which step-up therapy is more likely to be the most effective for a child with persistent asthma.

The study found that almost all of its participants had a different response to the 3 different treatments. Although adding the long acting beta-agonist step-up was 1.5 times more likely to be the best treatment for most of the study group, many children responded best to other 2 treatments instead.

The results were presented on March 2 at the 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in New Orleans and are published online in the New England Journal of Medicine.

“These results fill an important gap in our asthma guidelines,” said Susan B. Shurin, MD, National Heart, Lung, and Blood Institute (NHLBI). “At the time the guidelines were written, there were very few comparison studies conducted in children whose asthma was poorly controlled with low-dose inhaled corticosteroids. Now that we have these study data, we can more confidently make recommendations for these children.”

The NHLBI’s Guidelines for the Diagnosis and Management of Asthma (EPR-3) recommend 3 treatment options for children with mild to moderate persistent asthma (those experiencing symptoms at least 2 days per week or whose asthma is not well controlled on low doses of inhaled corticosteroids).

These treatments, which were featured in the study, are adding a long acting beta agonist to the low-dose inhaled corticosteroids; adding a leukotriene receptor antagonist to the low-dose inhaled corticosteroids; and doubling the dose of inhaled corticosteroids. These recommendations were based on data collected from adults.

The Best Add on Therapy Giving Effective Responses (BADGER) study compared how effectively the 3 different step-up treatments improved asthma control in 182 children aged 6 to 18 years. All participants had mild to moderate persistent asthma that was not controlled on low-dose inhaled corticosteroids. Participants received each of the 3 treatments, with each treatment period lasting 16 weeks.

Responses were measured based on 3 factors: number of asthma episodes requiring oral corticosteroids, number of days of well controlled asthma, and lung function as measured by the amount of air exhaled in one second.

Overall, adding a long-acting beta-agonist to inhaled corticosteroids was significantly more likely (1.5 times) to be the best step-up therapy as compared with adding a leukotriene receptor antagonist to inhaled corticosteroids or to doubling inhaled corticosteroids.

Nearly all the children responded differently to the three treatments, with 45% of children responding best to adding a long-acting beta-agonist, 28% responding best to adding leukotriene receptor antagonist, and 27% responding best to doubling the dose of inhaled corticosteroids.

The study also identified several patient characteristics that increased the likelihood of identifying which step-up treatment would be more effective for an individual child. For example, African-American study participants were equally likely to respond best to long-acting beta-agonist step-up or inhaled corticosteroids step-up, and least likely to respond best to leukotriene receptor antagonist step-up. For white participants, the addition of a long-acting beta-agonist was clearly the most likely step-up therapy to give the best response, with inhaled corticosteroids step-up the least favourable therapy.
In addition, a long-acting beta-agonist was more likely to be the most effective step-up therapy among children who started the study with high scores on the Asthma Control Test, and among those who did not have eczema.

“This study underscores the fact that individuals respond differently to different therapies - childhood asthma treatment is not one-size-fits-all,” said lead author Robert F. Lemanske, Jr., MD, University of Wisconsin Hospital-Madison, Madison, Wisconsin. “It is important to monitor the child’s response closely and, if necessary, adjust therapy with one of the other options within this step of care before moving to a higher step of care.”

The observed overall best performance of long-acting beta-agonist step-up should be weighed against the increased risk of severe worsening of asthma symptoms leading to hospitalisation and, in rare cases, death.

Although there were no safety differences among the treatments during this study, the researchers assert the BADGER trial was not designed or powered to evaluate long-term safety of long-acting beta-agonists in children.

SOURCE: National Institutes of Health

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