The Prevention of Asthma Exacerbations Using Dupilumab in Urban Children and Adolescents (PANDA) trial was launched in order to examine the effects of treatment on children with poorly controlled allergic asthma who live in low-income urban environments in the United States, according to the National Institute of Allergy and Infectious Diseases.
Black and Hispanic children who live in these environments are at particularly high risk for asthma and are prone to attacks. These children and adolescents 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, according to a June 2 NIAID press release.
PANDA is a multicenter, double-blind, placebo-controlled, randomized trial of dupilumab adjunctive therapy for the reduction of asthma exacerbations in urban children and adolescents 6-17 years with T2-high exacerbation-prone asthma. Approximately 240 participants will be randomized 2:1 to one of two study arms: 1) guidelines-based asthma treatment plus dupilumab, or 2) guidelines-based asthma treatment plus placebo. The planned study treatment will continue for 1 year with an additional 3 months of follow-up following completion of study treatment, according to the study details.
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
“We need to find out how well approved asthma drugs work for disadvantaged children of color living in urban areas, and whether biological markers can help predict how the drugs affect their asthma,” NIAID director Anthony S. Fauci, MD, said in the release. “The PANDA trial is an important step toward these goals.”
Participant criteria for the study include children of either sex, ages 6-17 years, who live in prespecified urban areas. Participants must have a diagnosis of asthma and must have had at least two asthma exacerbations in the prior year (defined as a requirement for systemic corticosteroids and/or hospitalization). At the screening visit, participants must have the following requirements for asthma controller medication: For children ages 6-11 years: treatments with at least fluticasone 250 mcg dry powder inhaler (DPI) one puff twice daily or its equivalent; for children ages 12 years and older, treatment with at least fluticasone 250 mcg plus long-acting beta agonist (LABA) DPI one puff twice daily or its equivalent.
ClinicalTrials.gov Identifier: NCT05347771Location: 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.
Sponsor: NIAID, Regeneron Pharmaceuticals and Sanofi are cofunding the phase 2 trial.
Study start date: April 2022
Expected completion Date: March 31, 2025