• Step-up therapy benefits children with asthma

    May 2010

    For children whose asthma is not well controlled, new research offers three types of added therapy that can provide relief. All three therapies use corticosteroid inhalers in combination with either a long-acting beta-agonist (LABA), a leukotriene-receptor antagonist (LTRA) or an increased dose of corticosteroids.


    Until recently, there hasn't been much data to guide doctors when dealing with difficult-to-control asthma. 


    Asthma, a lung disease that makes breathing difficult because the airways become inflamed and narrowed, affects approximately 7 million American children. Since the 1980s, the incidence of the disease has more than doubled. It is a very costly disease, accounting for 500,000 hospitalizations a year, 10.5 million physician-office visits and 3,500 deaths, as well as millions of missed school days.

    There is no cure for asthma, but it is treatable. However, until recently, there hasn't been much data to guide doctors when dealing with difficult-to-control asthma.

    BADGER study

    The current study, called Best Add on Therapy Giving Effective Responses (BADGER) is the first of its kind to compare the effectiveness of the three step-up treatments. The 182 children in the study, ages 6 to 18, had mild to moderate asthma that was not controlled on low-dose inhaled steroids alone. The study was published in the March 2, 2010, issue of The New England Journal of Medicine. 

    Nearly all of the children in the study responded differently to each step-up therapy: 45 percent responded best with LABAs as the add-on therapy; 28 percent with an LTRA; and 27 percent with doubling the dose of inhaled steroids. Seven serious adverse events were reported, the most serious being asthma exacerbation. “Our findings suggest that there is a ceiling effect of low-dose inhaled corticosteroids in many, though not all, children,” the study authors wrote. “Our data show that to achieve improvements in asthma control, the addition of a different class of medication is often required.”

    However, since there were improvements with all three treatments, they stressed the need to regularly monitor and appropriately adjust each child's asthma therapy.

    Researchers also found that certain patient characteristics identified which step-up treatment would be most effective. African- American children were equally likely to respond best to LABAs or steroid step-up but not the LTRA, whereas white patients had the best response with LABAs and the least favorable with increased inhaled steroids. The LABAs were especially likely to help patients who did not also have eczema.


    “...to achieve improvements in asthma control, the addition of a different class of medication is often required.” – Study authors. 


    Safety concerns

    However, the BADGER study was not designed to look at safety, they caution, and the benefits of LABAs in particular must be weighed against the risks cited by the U.S. Food and Drug Administration (FDA). Various studies of the use of the LABA salmeterol showed a small increase in the risk of death and hospitalization, as well as breathing problems, particularly among African-American patients. For this reason, the FDA placed a “black box” warning on medication containing the LABAs salmeterol or formoterol. One of the most common is the inhaled medication sold commercially as Advair. The FDA has since revised its warning in light of the fact that many patients previously studied were not taking an inhaled steroid along with the LABA. Furthermore, a review of research showed there were no adverse effects in patients who were taking an inhaled steroid along with the LABA.

    The FDA now states that an LABA medication should not be used if a person's asthma is controlled by steroids alone. In cases of poorly controlled asthma, LABAs may be used with inhaled medications. However, LABAs should not be used alone.

  • More information
  • Related resources

    For more information, see:

    Step-up therapy for children with uncontrolled asthma receiving inhaled corticosteroids, The New England Journal of Medicine, v. 362, no. 11, March 18, 2010

    Asthma in children, MedlinePlus, National Library of Medicine

    Anti-inflammatories and corticosteroids, American Association for Respiratory Care

    Asthma in Children, Health Information, UK HealthCare

    Childhood Asthma Quiz, Health Information, UK HealthCare

  • UK HealthCare Pediatric Services - Kentucky Children’s Hospital

    For more information, or to make an appointment with a UK HealthCare physician, please call UK Health Connection at 1-800-333-8874. 

Page last updated: 5/21/2014 9:29:06 AM
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    What the news means for you

    Asthma can be controlled

    Jamshed F. Kanga, MD, FCCP
    Pediatric Pulmonologist

    Wright, Heather, MDOver the last 10 years, the National Institutes of Health has emphasized control of asthma. Patients with this disease should be able to lead a normal life, take part in normal activities, sleep through the night without symptoms and infrequently have to use their asthma rescue medication. Yet even today, with all the new medications we have, asthma isn't being adequately controlled, costing billions of dollars to our health care system.


    “The major reason asthma is uncontrolled or poorly controlled is poor adherence to therapy.” 


    The recommendations are that we evaluate patients every three to six months, check their history and get a lung function test. Based on their control of asthma, we can either step up therapy or start cutting down. Two types of medication are used: controller medications – used daily to control inflammation in the airways; and rescue medications, which relax the muscles and make it easier to breathe when the controller medications aren't enough.

    Well-controlled asthma

    To determine the degree of asthma control, we have what we call the Rule of 2. When asthma is well-controlled, the patient should:

    • have asthma symptoms fewer than two days a week,
    • be awakened fewer than two days a month by symptoms, and
    • need to use a rescue inhaler fewer than two days a week.

    Some patients may meet all of these criteria yet have a serious flare-up requiring hospitalization or oral corticosteroids. This shouldn't happen more than once every six months in order for the asthma to be considered adequately controlled.


    “If asthma is adequately controlled, a person should be able to participate in sports and lead a normal life.” 


    Step-up therapies

    The BADGER study shows that using LABAs with steroids is safe and effective. Combination inhalers on the market contain both medications, but it's important not to use LABAs without trying inhaled corticosteroids alone first, and LABAs should never be used without steroids. Using LABAs alone puts the patient at higher risk for severe reactions or even death. Plus, some patients may be more sensitive to this class of drug.

    The major reason asthma is uncontrolled or poorly controlled is poor adherence to therapy. Sometimes patients just don't take their medication. It may be because they're depressed or, in the case of adolescents, they are rebelling. In some instances, patients are not on adequate therapy because their doctor doesn't think their asthma is bad enough. Other factors that can lead to uncontrolled asthma include poor technique in using the inhaler; a lack of environmental controls; the need for another medication; and conditions such as allergic rhinitis, chronic sinusitis or acid reflux.

    Diagnosing and treating asthma

    Asthma often goes undiagnosed. The doctor may assume a patient's cough is due to bronchitis, but often what we call “chronic bronchitis” is actually asthma. Sometimes the pediatrician or the family may be reluctant to label a child as “asthmatic,” so there is a failure to recognize the symptoms.

    A lung function test is not conclusive in diagnosing asthma because the patient may have normal lung function. The best way to make a diagnosis is by taking the patient's history.

    Unfortunately, asthma medications are very expensive and are not available in generic form. Patient assistance programs available from some drug companies exist, but some patients survive on sample medications they get from their doctor's office.

    Steroids today are much safer, although they can in some cases cause thrush mouth in children. Rinsing the mouth out thoroughly after using the inhaler and brushing the teeth can help prevent thrush. And even though there's some evidence that steroids can stunt a child's growth, most children will eventually catch up to their normal growth.

    Patient education

    Education is a big part of what we do at UK HealthCare. We have many resources as well as nurses and respiratory therapists who can help patients learn how to use different inhalers.

    If asthma is adequately controlled, a person should be able to participate in sports and lead a normal life. There are Olympic athletes who have asthma, but you have to use your controller medications daily and not just when you're sick.

    In the United States, 5,000 people die every year from asthma. It is sad that in most of these cases, death could have been prevented with good asthma therapy and education.

    Dr. Kanga is chief of pediatric pulmonology and professor of pediatrics at the UK College of Medicine and an attending physician at Kentucky Children's Hospital.. 

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