Asthma and wheezing can disrupt simple daily activities in children.

6.3 million children

Childhood asthma affects over 6 million children nationwide, and nearly 1 million of those children are under 4 years of age. But, asthma doesn’t just spring up overnight. It starts out as wheezing illnesses and as a child grows, so does the disease that may follow him or her around for a lifetime. Asthma is the most common chronic disease in childhood, and causes nearly 14 million missed school days and most unexpected hospital visits each year nationwide.

What if there was a chance to reduce early wheezing and in doing so, reduce asthma later in life?

That’s what the ORBEX Clinical Study aims to do. The purpose of the ORBEX Clinical Study is to test to see if a medication can help prevent the development of wheezing in young children.

This is supported by a recently published article in the New England Journal of Medicine. The article provides details on a study of the Amish and Hutterite populations, where the Amish and Hutterite populations had “marked differences in the prevalence of asthma despite similar genetic ancestors and lifestyles.2” The conclusion of the study is that the increased exposure to microbes, due to the differences in farming techniques and environments, is the reason the Amish children had a significantly lower rate of asthma (none of the Amish children tested had asthma). The exposure to the microbes provides protection against asthma by engaging and shaping a person’s natural immune response.

2 Stein, M. M., Hrusch, C. L., Gozdz, J., Igartua, C., Pivniouk, V., Murray, S. E., . . . Sperling, A. I. (2016). Innate Immunity and Asthma Risk in Amish and Hutterite Farm Children. New England Journal of Medicine N Engl J Med, 375(5), 411-421. doi:10.1056/nejmoa1508749

Asthma and Wheezing in Children

According to the National Heart, Lung and Blood Institute, an institute in the National Institutes of Health, asthma is a chronic lung disease that inflames and narrows a person’s airways. There is currently no cure for asthma, and while it affects people of all ages, it most often starts during childhood. Symptoms include chest tightness, shortness of breath and coughing.

In 2014, there were 24 million people living with asthma in the United States - 17.7 million adults and 6.3 million children (under 18 years of age). Asthma affects children between the ages of 5 and 14 at a higher rate. Asthma can also appear in young children before the age of 5, but is often harder to diagnose. This is because asthma symptoms may occur with other conditions such as a cold or respiratory infections. However, an early indicator of asthma in young children is wheezing.

Why Participate in a Clinical Study?

There is a good reason.

First, it is important to know that there is no guarantee that your child will benefit from participating.

Your child's participation in the ORBEX Clinical Trial may help children in the future live healthier lives. Through this clinical trial, we will learn more about using Broncho-Vaxom to prevent wheezing and asthma-like symptoms in toddlers who may be at risk for developing asthma. This could potentially have a very big and lasting impact on the health of children nationwide.

But why not just have adults with asthma participate? There are two reasons, the first being that one of the goals of the ORBEX Clinical Trial is to see if the use of Broncho-Vaxom can prevent the occurrence of early wheezing and in doing so, reduce asthma later in life. Since asthma is a chronic disease and typically manifests during childhood, testing the potential preventive effect of Broncho-Vaxom must occur when a person is a child.

Secondly, clinical studies with child participants are extremely important to the health of all children. According to the National Health, Lung, and Blood Institute, many doctors often have to use treatments based on what is known to work in adults. This is because not all medications are tested in both adults and children. Research studies that specifically study medication use in children can help doctors by providing more precise information on the best medication dosage for kids.

So what clinical trials that include child participants do is produce better findings that increase pediatric safety, such as dosing, whether or not a drug is effective for children, or new data that wasn’t known before.

According to the National Institutes of Health a young child who has frequent wheezing with colds or respiratory infections is more likely to have asthma if:

  • One or both parents have asthma;
  • Child has signs of allergies;
  • Child has eczema (children with eczema are 46% more likely to develop asthma1);
  • Child has allergic reactions to pollens or other airborne allergens; and
  • Child wheezes even when he/she does not have a cold or other infection.

1 Carlsen, B. C., Menne, T., and Johansen, J. D. 20 Years of standard patch testing in an eczema population with focus on patients with multiple contact allergies. Contact Dermatitis, 2007, 57: 76-83.