Benralizumab for Asthma
(AERFLO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests benralizumab, a drug designed to help people with severe, hard-to-control asthma. Benralizumab reduces eosinophils, a type of white blood cell that can inflame the airways in some asthma patients. The study will determine if this treatment improves lung function, reduces breathing problems, and enhances participants' quality of life. Individuals with a history of poorly controlled asthma who have not smoked for at least a year might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to valuable research that could lead to better asthma treatments.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that chronic maintenance prednisone for asthma is allowed, and you must have been on certain asthma medications for at least 12 months before joining. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that benralizumab is likely to be safe for humans?
Research has shown that benralizumab is generally well-tolerated by people with severe asthma. In one study, about 76% of people taking benralizumab and 80% of those taking a placebo (a fake treatment) experienced side effects. This indicates that benralizumab does not cause more side effects than no treatment at all.
Another study examined the long-term use of benralizumab and found that many patients experienced fewer asthma attacks, with no new safety issues emerging. This suggests the treatment is safe for ongoing use.
Real-world data also supports its safety. In a group of 632 people, many did not report serious problems with the drug, reinforcing the evidence that benralizumab is safe for people with severe, uncontrolled asthma.
Overall, current studies suggest that benralizumab is safe and well-tolerated. However, as with any treatment, individuals might react differently. Always consult a healthcare provider before deciding to join a clinical trial.12345Why are researchers excited about this trial?
Benralizumab is unique because it targets and depletes eosinophils, which are inflammatory cells that play a significant role in asthma, by binding to the interleukin-5 receptor. This mechanism is different from many standard asthma treatments, like inhaled corticosteroids and bronchodilators, which focus on reducing inflammation and opening airways without specifically targeting eosinophils. Researchers are excited about benralizumab because it offers a more tailored approach, potentially leading to better control of symptoms for patients with eosinophilic asthma. Additionally, its administration as a subcutaneous injection could make it a convenient option for those who prefer less frequent dosing than daily inhalers.
What evidence suggests that benralizumab might be an effective treatment for asthma?
Research has shown that benralizumab, the treatment under study in this trial, can improve symptoms in people with severe eosinophilic asthma, which involves a type of white blood cell. Studies have found that benralizumab reduces asthma flare-ups by 51% when used with regular treatment. Additionally, nearly 60% of patients experienced no flare-ups during long-term use. By targeting and reducing these specific white blood cells, benralizumab improves lung function and controls asthma symptoms. This evidence suggests that benralizumab could be a promising option for people with severe, hard-to-control asthma.12346
Who Is on the Research Team?
Grace E Parraga, PhD
Principal Investigator
Robarts Research Institute, The University of Western Ontario
Are You a Good Fit for This Trial?
Adults aged 18-70 with severe, poorly controlled eosinophilic asthma who have been on high-dose inhalers and additional medications. They must not smoke, be able to use effective birth control if applicable, and have a history of responding to bronchodilators or positive methacholine tests. Excluded are those with other significant health issues, metal implants incompatible with MRI, recent drug abuse, or certain medication use.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive benralizumab 30mg subcutaneous injection on study days 0, 28, and 56, with MRI and other assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments on Day 112
Open-label extension (optional)
Participants may opt into continuation of benralizumab treatment every 8 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Benralizumab
Benralizumab is already approved in European Union, United States, Canada, Japan for the following indications:
- Severe eosinophilic asthma
- Severe asthma with an eosinophilic phenotype
- Severe eosinophilic asthma
- Severe eosinophilic asthma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dr. Grace Parraga
Lead Sponsor
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology