Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment

This study is looking for people with eosinophilic asthma, which means your asthma is linked to specific immune cells called eosinophils. You need to be between 12 and 75 years old and weigh at least 35 kg. You should have been diagnosed with asthma for at least a year and currently be using a medium-dose inhaler (ICS-LABA) for at least three months, with or without other asthma medicines (but not steroid tablets).

Your asthma should not be well-controlled. This means you've had at least two asthma flare-ups in the past year that needed treatment, and your asthma control score (ACQ-6) shows your asthma isn't fully under control. Also, your breathing tests (FEV1) should show some reduced lung function, and blood tests must confirm you have elevated levels of eosinophils in your blood.

There are also some reasons you might not be able to join. For example, if you have other serious lung diseases, had an asthma flare-up or severe infection recently, or have certain other health conditions that the study doctor thinks could affect your participation. You also can't be in another clinical trial at the same time.

If you join this study, it will run for about 18 months, with regular visits to the clinic. Initially, you'll have some screening appointments to make sure you're a good fit. Once enrolled, you'll be randomly assigned to one of two groups: either you'll add benralizumab injections to your current medium-dose inhaler, or you'll increase your inhaler to a high dose and receive a dummy injection (placebo).

Benralizumab will be given as an injection under the skin. For the first few doses, you'll get it every 4 weeks. After that, it will be every 8 weeks. You'll need to keep a daily diary of your asthma symptoms and inhaler use. Throughout the study, you'll have various assessments, including blood tests, breathing tests (like FEV1), and physical exams to monitor your asthma and overall health. You'll also be asked about any side effects you might experience. Regular follow-up appointments will ensure your safety and track your progress.