What side effects are associated with this type of intervention?

Common treatments for bronchiectasis, particularly those involving anti-eosinophil monoclonal antibodies like benralizumab, often include biologics targeting IL-5 or IL-5R. Known side effects of these treatments can include injection site reactions, headache, nasopharyngitis, and upper respiratory tract infections. Additionally, there may be a risk of more serious adverse events such as hypersensitivity reactions and, in rare cases, cardiac events. It is important for patients to discuss these potential side effects with their healthcare provider to weigh the benefits and risks.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for the treatment of Bronchiectasis using drugs similar to Benralizumab in the provided context. Benralizumab is an anti-eosinophil monoclonal antibody targeting IL-5R, primarily studied for conditions involving eosinophilic inflammation, such as severe asthma. For Bronchiectasis, treatments typically focus on managing symptoms and preventing exacerbations, but specific FDA-approved biologics targeting eosinophilic pathways for this condition are not detailed in the context.

What other types of research exist?

Promising novel alternatives to Benralizumab for Bronchiectasis patients include Dupilumab, an IL-4 and IL-13 inhibitor, and Omalizumab, an anti-IgE monoclonal antibody. Both have shown efficacy in related respiratory conditions and are being explored for their potential benefits in bronchiectasis.

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Monoclonal Antibodies

Benralizumab for Bronchiectasis (MAHALE Trial)

Phase 3

Waitlist Available

Led By James D. Chalmers, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Documented history of 2 or more bronchiectasis exacerbations within a year of the screening visit.

Must be on airway clearance therapy, physiotherapy, or mucus clearance therapy.The dose and regimen of these therapies and any drugs used to aid expectoration should be stable for at least 3 months prior to the screening visit and remain stable throughout the DB period of the study.

Must not have

Current active liver disease

Use of immunosuppressive medication within 3 months of the screening visit or expected need for chronic use (≥ 4 weeks) during study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over the db treatment period (28 to 52 weeks)

Awards & highlights

Pivotal Trial

Summary

This trial tests if benralizumab can reduce lung flare-ups in adults with a specific lung condition involving high eosinophil levels. The medication works by lowering certain white blood cells that cause inflammation. Benralizumab helps improve lung function for patients with severe, uncontrolled asthma with eosinophilic inflammation.

Who is the study for?

Adults over 18 with non-cystic fibrosis bronchiectasis confirmed by CT, experiencing at least two exacerbations in the past year. They must be on stable airway clearance or mucus therapy for three months prior to screening and agree to use effective birth control if applicable. Excluded are those with recent infections, drug abuse history, other diseases causing high eosinophil counts, certain cancers, unstable health conditions, or using specific treatments like long-term oxygen.

What is being tested?

The trial is testing Benralizumab against a placebo in addition to standard care for reducing exacerbation rates in patients with bronchiectasis and eosinophilic inflammation. It's a phase III study where participants are randomly assigned to either the medication or placebo group and may enter an open-label extension after completing initial treatment.

What are the potential side effects?

While not specified here, common side effects of drugs like Benralizumab can include headache, fatigue, allergic reactions at injection site. More serious risks might involve weakening of immune system leading to increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I've had 2 or more flare-ups of my lung condition in the last year.

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I have been on a stable lung therapy for mucus clearance for at least 3 months.

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My asthma medication dose has been stable for the last 3 months.

Exclusion Criteria

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

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I have an ongoing liver condition.

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I haven't taken immunosuppressive drugs in the last 3 months and don't expect to need them.

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I am on long-term oxygen therapy.

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I haven't taken any experimental drugs within the last 30 days or 5 half-lives.

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I have not received any live vaccines in the last 30 days.

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I have smoked at least 10 pack-years.

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I have had a lung infection or worsening of my bronchiectasis recently.

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I have a condition that increases my eosinophil count.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over the db treatment period (28 to 52 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over the db treatment period (28 to 52 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and over the db treatment period (28 to 52 weeks) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Annualised exacerbation rate

Secondary study objectives

Change from baseline in LCQ

Change from baseline in QoL-B scales (excluding QoL-B-RSS secondary endpoint)

Change from baseline in QoL-B-RSS

+3 more

Other study objectives

Anti-drug antibodies (ADA) as a measure of immunogenicity

Serum benralizumab concentration as a measure of pharmacokinetics

Side effects data

From 2016 Phase 3 trial • 220 Patients • NCT02075255

15%

Nasopharyngitis

Asthma

Sinusitis

Headache

Bronchitis

Upper respiratory tract infection

Influenza

Back pain

Cough

Dyspnoea

Hypertension

Rhinitis

Urosepsis

Nephrolithiasis

Intervertebral disc protrusion

Umbilical hernia

Adverse drug reaction

Hypersensitivity

Vertigo

Nausea

Dermatitis atopic

Urinary tract infection bacterial

100%

80%

60%

40%

20%

Study treatment Arm

Benra 30 mg q.4 Weeks

Benra 30 mg q.8 Weeks

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BenralizumabExperimental Treatment1 Intervention

Benralizumab will be administered subcutaneously (SC) using an accessorized prefilled syringe (APFS)

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo solution will be administered subcutaneously (SC) using an accessorized prefilled syringe (APFS)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Benralizumab

2016

Completed Phase 4

~10320

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Bronchiectasis include antibiotics, bronchodilators, and anti-inflammatory agents. Antibiotics target bacterial infections, reducing inflammation and preventing exacerbations. Bronchodilators, such as beta-agonists and anticholinergics, relax airway muscles, improving airflow and reducing symptoms. Anti-inflammatory agents, including corticosteroids and monoclonal antibodies like Benralizumab, reduce inflammation by targeting specific pathways. Benralizumab, an anti-eosinophil monoclonal antibody, targets the IL-5 receptor, reducing eosinophil levels and inflammation. This is crucial for Bronchiectasis patients as it helps manage chronic inflammation, reduces exacerbations, and improves overall lung function.