A comparative study of Dupilumab versus Omalizumab in severe pediatric asthma: a multicenter, randomized and controlled clinical trial

Abstract

BACKGROUND: Asthma is a very common chronic respiratory disease The prevalence is increasing in many countries, especially among children. Majority of children with asthma respond well to standard therapies, however a significant proportion still have severe disease that is resistant to conventional therapies. Biologic therapies are increasingly being considered in children with severe asthma. Monoclonal antibodies as add-on therapy have been shown to reduce exacerbations and improve symptom control, improving patients' quality of life. Although all biologic therapies have demonstrated significant benefits, each has its own particular characteristics. Selecting the most appropriate therapy for an individual patient is a challenge for specialists, as there are no established algorithms available to assist choice. AIM: To compare the efficacy of different biologic therapies, dupilumab and omalizumab, in children with uncontrolled asthma with a combination of high dose inhaled corticoesteroids (ICS) and long-acting b2-adrenergic agonist (LABA). This strategy is expected to reduce the number of emergency department visits and admissions to hospital due to asthma worsening. A reduction in the use of systemic corticosteroids and a better control of the disease are also expected. METHODS: A prospective multicenter clinical trial will be conducted in 388 patients diagnosed with asthma who remain uncontrolled with high dose of ICS combined with LABA. All hospitals in the province of Girona will participate in this study. Hospitals participating will recruit study subjects by consecutive sampling and divide them into two groups, the intervention group and the control group. Intervention: Both groups will be equally informed of all non-pharmacological strategies for asthma management and both will continue with their baseline treatment. The intervention group will receive add-on treatment with dupilumab while the control group will receive omalizumab. Outcomes: Asthma control level, ACT score and total number of exacerbations, emergency department visits, hospital admissions and use of systemic corticosteroids during the intervention time will be evaluated. At the end, a statistical analysis of the data collected will be performed, taking into account all covariates