NIH Launches Trial of Monoclonal Antibody to Treat Asthma in Urban Youth

NIH has launched a clinical trial testing whether a monoclonal antibody, dupilumab, can reduce asthma attacks and improve lung function and asthma symptoms in children with poorly controlled allergic asthma who live in low-income urban neighborhoods. The investigators also aim to define the activity levels of asthma-associated gene networks that correspond to specific health outcomes during antibody treatment in these children, most of whom are anticipated to be Black or Hispanic. 

NIAID, Regeneron Pharmaceuticals Inc. and Sanofi are co-funding the phase 2 trial, called Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents, or PANDA. The NIAID-funded Childhood Asthma in Urban Settings (CAUSE) Network is conducting the study at seven medical centers located in Aurora, Colo.; Boston; Chicago; Cincinnati; New York; and Washington, D.C. 

Dupilumab is FDA-approved as an add-on maintenance treatment for certain types of moderate-to-severe asthma in people ages 6 years and older. However, little data exist on the effectiveness of the drug in Black and Hispanic children, who are disproportionately affected by severe asthma. 

Black and Hispanic children who live in low-income urban environments in the U.S. are at particularly high risk for asthma attacks. These children often have many allergies and are exposed to both high levels of indoor allergens and traffic-related pollution, which can make their asthma even more difficult to control.

In an earlier study, NIAID-supported investigators identified numerous networks of genes that are activated together and are associated with asthma attacks in minority children and adolescents living in low-income urban settings. Some of these gene networks are specifically associated with a systemic allergic response called Type 2 inflammation, shown to play a major role in asthma in this population. 

Because dupilumab works by blocking interleukin 4 and interleukin 13, two small proteins involved in Type 2 inflammation, PANDA investigators hypothesize that the drug will reduce asthma attacks and improve lung function and asthma symptoms in study participants.

The PANDA study team will enroll approximately 240 participants ages 6 to 17 years who have poorly controlled allergic asthma that is prone to attacks and who have biological markers of Type 2 inflammation. All participants also will receive asthma care based on NHLBI guidelines.