Benralizumab for Asthma

(AERFLO Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Grace E Parraga, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Dr. Grace Parraga

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effect of a drug called benralizumab in individuals with severe, poorly controlled asthma with eosinophilic airway inflammation. Eosinophils are a type of white blood cell that help fight off infections. Some people with asthma have too many eosinophils in their airways and blood, which can cause airway inflammation. Benralizumab is a new drug that is Health Canada approved and has been shown to rapidly eliminate eosinophils. It has been used in patients with severe asthma to improve lung function and reduce flair-ups, also known as exacerbations. Magnetic Resonance Imaging (MRI) is an imaging tool that can look at the structure of the lungs when a subject inhales a xenon gas mixture. In healthy individuals, the gas fills the lungs evenly, but in individuals with lung disease, some of the areas of the lungs are not filled by the gas and the image looks patchy. These patchy areas are called ventilation defects and they contribute to reduced lung function. The goal of the study is to see if treatment with benralizumab will improve these ventilation defects, overall lung function and blood and sputum eosinophil levels. Subjects will receive treatment with benralizumab a total of 3 times, 4 weeks apart. Before and after treatment, subjects will undergo a series of MRI tests, breathing tests, blood and sputum analysis and a series of questionnaires to evaluate daily quality of life. The hypothesis is that ventilation defects will significantly improve after benralizumab treatment, and that this improvement will be different based on how long the patient has had asthma.

Research Team

Grace E Parraga, PhD

Principal Investigator

Robarts Research Institute, The University of Western Ontario

Eligibility Criteria

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

I am using a reliable method of birth control or am not sexually active.

I have shown significant improvement in lung function tests or had a positive asthma test in the last 2 years.

I have been using high-dose asthma inhalers and long-term breath aids for over a year.

Exclusion Criteria

You have struggled with alcohol or drug abuse in the past year.

I am a new mother, within 8 weeks post-partum or currently breastfeeding.

You have had a severe allergic reaction to any biologic therapy in the past.

Treatment Details

Interventions

• Benralizumab (Monoclonal Antibodies)

Trial Overview The trial is testing benralizumab's effect on lung function in severe asthma patients by using Hyperpolarized 129-Xenon MRI imaging. Participants will receive three doses of benralizumab four weeks apart while undergoing MRIs, breathing tests, blood/sputum analysis and quality of life questionnaires before and after treatment.

Participant Groups

Group I: Treatment Experimental Treatment 2 Interventions

Benralizumab 30mg subcutaneous injection on study days 0, 28 and 56 and 1.0 L 129-Xenon/4-Helium mixture, twice per visit, on days 0, 14, 28 and 112.

Benralizumab is already approved in Canada, Japan for the following indications:

Approved in Canada as Fasenra for:

• Severe eosinophilic asthma

Approved in Japan as Fasenra for:

• Severe eosinophilic asthma

Who Is Running the Clinical Trial?

Dr. Grace Parraga

Lead Sponsor

Trials

6

Recruited

490+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

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