This is a randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of dupilumab in children 6 to < 12 years of age with uncontrolled persistent asthma. The purpose of this study is to assess how safe and effective dupilumab is compared with placebo for the treatment of uncontrolled persistent asthma in children ages 6 to less than 12 years of age and how well it is tolerated. To date dupilumab has been studied in 5 clinical trials and in the 2 completed asthma trials, dupilumab improved breathing and reduced symptoms of asthma. This study is being funded by Sanofi Australia Pty Ltd.

Asthma is a chronic disease that affects the airways, making them very sensitive to exercise, infections, pollution and other irritants.  These cause the airways to narrow making it difficult to breathe. Symptoms of asthma include wheezing, shortness of breath, chest tightness and coughing. Symptoms are often worse at night and in the early morning. While there is no cure for asthma, the condition may be controlled. It is hoped that Dupilumab will help these children with asthma control.

In this study the treatment is given for 52 weeks and then followed for 12 weeks without any treatment. The study medication is given as a subcutaneous injection every 2 weeks for 52 weeks. Daily electronic symptom diary and PEF needs to be completed throughout the study. During the study we will be doing tests like spirometry, FeNO and ECG and collecting blood and urine samples at different time points.

The recruitment is open for this study. For enquiries about the study please contact the clinical team on clear@uq.edu.au