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Monoclonal Antibodies

Benralizumab for Asthma (AERFLO Trial)

N/A

Waitlist Available

Led By Grace E Parraga, PhD

Research Sponsored by Dr. Grace Parraga

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women of childbearing potential (after menarche) must use a highly effective form of birth control (confirmed by the investigator or designee). A highly effective form of birth control includes true sexual abstinence, a vasectomized sexual partner, Implanon®, female sterilization by tubal occlusion, any effective intrauterine device (IUD)/levonorgestrel intrauterine system (IUS), Depo-Provera (trademark) injections, oral contraceptive and Erva Patch (trademark) or Nuvaring (trademark)

Patient has documented treatment with medium- to high-dosage inhaled corticosteroids (ICS) (>250μg fluticasone dry powder formulation equivalents total daily dosage) and a long-acting β2-agonist (LABA) for at least 12 months prior to enrolment.

Must not have

Patient has clinically important pulmonary disease other than asthma (e.g. active lung infection, chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha-1 antitrypsin deficiency and primary ciliary dyskinesia) or been diagnosed with pulmonary or systemic disease other than asthma that is associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome), except for those atopic conditions that can be associated with asthma (e.g. allergic rhinitis, sinusitis with or without polyposis, eczema, and eosinophilic esophagitis)

Patient is a female who is ≤8 weeks post-partum or breast feeding an infant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0, 28, 56 and 112

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate if a drug called benralizumab can reduce airway inflammation and improve lung function in people with severe asthma. MRI, breathing tests and questionnaires will be used to measure the effect of the drug.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Benralizumab may cause side effects such as headache, sore throat (pharyngitis), fever (pyrexia), fatigue, injection site reactions (e.g., pain or redness), muscle pain (myalgia) and possible hypersensitivity reactions including anaphylaxis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I have been on high dose asthma medication and long-acting inhalers for at least 3 months.

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I haven't smoked tobacco or cannabis for over a year and have smoked less than 1 pack a day for 1 year in my life.

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I agree to use double barrier contraception during and 16 weeks after the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious lung condition other than asthma or a disease that increases my eosinophil counts.

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

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I am allergic to the medication used in this study.

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I am scheduled for surgery during the study.

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I am currently taking medication like propranolol.

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I cannot hold my breath for an MRI.

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I have heart issues like a past heart attack or heart muscle disease.

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I haven't taken any biologic drugs recently and my blood eosinophil count is high.

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I have not donated blood in the last 4 weeks and will not during the study.

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I have been hospitalized or had major surgery, trauma, or illness within the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0, 28, 56 and 112

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0, 28, 56 and 112

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0, 28, 56 and 112 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline airway function measured using 129-Xenon MRI ventilation defect percent

Secondary study objectives

Change from baseline airways resistance

Change from baseline forced expiration volume in one second

Change from baseline forced oscillation technique

+9 more

Other study objectives

Explore univariate correlation and linear regression of MRI ventilation defect percent and airways resistance

Explore univariate correlation and linear regression of MRI ventilation defect percent and asthma control as measured by the Asthma Control Questionnaire

Explore univariate correlation and linear regression of MRI ventilation defect percent and asthma-related quality of life as measured by the Asthma Quality of Life Questionnaire

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