A new study led by researchers at Boston Children’s Hospital aims to determine whether monoclonal antibody Xolair (omalizumab) can stop or lessen the progression of asthma in high-risk children.
About 10% of children in the United States have been diagnosed with asthma. According to studies, a large majority of these children also have allergies. Researchers working on the clinical trial Preventing Asthma in High Risk Kids (PARK) seek to determine whether early intervention with Xolair in young children with allergies can alter the processes that eventually lead to the development of asthma.
“PARK’s goal is to determine if early interruption of immunoglobulin E (allergic) mediated pathways in children ages 2 to 3 can prevent or modify the course of asthma in high-risk children,” says Wanda Phipatanakul, MD, MS, Director of the Asthma Clinical Research Center at Boston Children’s Hospital and lead researcher of the PARK study. “We hope that blocking these processes early in life, when a high-risk child is beginning to develop disease processes but prior to the full development of established disease, could have lasting benefit and prevent asthma and/or reduce the severe progression of asthma later on in life.”
Studies show as many as 80% of children who have allergies and wheezing episodes between the ages of 2 to 3 will develop asthma during childhood. While treatments can reduce symptoms, nothing has been proven to prevent the progression to asthma.
Xolair works by blocking immunoglobulin E (IgE), antibodies released in response to allergens such as pollen and mold spores. IgE antibodies attach to mast cells, which release histamine and trigger asthma and allergic responses. Mast cells also curb the creation of Treg cells, regulatory T cells that work to control the immune response.
Researchers hope that by blocking the immune events caused by IgE antibodies, the processes that lead to asthma can be thwarted. While Xolair is FDA-approved for use in people ages 6 and older with moderate to severe asthma, it has not yet been tested in younger children who are only developing allergies.
A Comprehensive Study
The PARK study is a randomized, double-blind trial that will study 250 children ages 2 and 3 at multiple research facilities.
“We are focused on children at high risk who are already beginning to develop symptoms,” Dr. Phipatanakul says. “We have targeted high-risk children as those who are allergic to allergens and starting to wheeze who also have a family history of asthma or allergies.”
Children in the trial will be given either Xolair or a placebo monthly for a two-year period. Researchers will continue to follow them for two more years after the treatment period to observe if and how many children from each group progress to asthma.
To learn more about the PARK trial, visit parkstudy.org.