Benralizumab for Bronchiectasis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Research Site, Haikou City, China
Bronchiectasis+2 More
Benralizumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether benralizumab can reduce exacerbation rates in patients with non-cystic fibrosis bronchiectasis.

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Eligible Conditions

  • Bronchiectasis
  • Non-cystic Fibrosis Bronchiectasis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Bronchiectasis

Study Objectives

This trial is evaluating whether Benralizumab will improve 1 primary outcome, 13 secondary outcomes, and 2 other outcomes in patients with Bronchiectasis. Measurement will happen over the course of During first 52 weeks.

During first 52 weeks
Time to first bronchiectasis exacerbation
Over first 52 weeks
Annualised exacerbation rate
over 52 weeks
Annualised rate of hospitalisations due to bronchiectasis exacerbations
Annualised rate of severe bronchiectasis exacerbations
Anti-drug antibodies (ADA) as a measure of immunogenicity
Change from baseline in LCQ
Change from baseline in QoL-B scales (excluding QoL-B-RSS key secondary endpoint)
Change from baseline in QoL-B-RSS
Change from baseline in SGRQ
Change from baseline in pre-dose FEV1
Frequency and annual rate of NCFB-related healthcare encounters
Frequency and annual rate of NCFB-related tests/procedures
Frequency of antibiotic use for bronchiectasis exacerbations
Safety and tolerability of benralizumab
Serum benralizumab concentration as a measure of pharmacokinetics
Total hospital length of stay per healthcare encounter

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Bronchiectasis

Side Effects for

Benra 30 mg q.4 Weeks
Nasopharyngitis
15%
Asthma
8%
Sinusitis
7%
Headache
7%
Bronchitis
7%
Upper respiratory tract infection
6%
Influenza
4%
Rhinitis
3%
Back pain
3%
Dyspnoea
3%
Cough
3%
Hypertension
3%
Adverse drug reaction
1%
Umbilical hernia
1%
Hypersensitivity
1%
Intervertebral disc protrusion
1%
Nephrolithiasis
1%
Vertigo
1%
Nausea
1%
Dermatitis atopic
1%
Urinary tract infection bacterial
1%
Urosepsis
1%
Pneumonia staphylococcal
0%
Status asthmaticus
0%
Oesophagitis
0%
Atypical pneumonia
0%
Presyncope
0%
Pericarditis
0%
Sleep apnoea syndrome
0%
Oral candidiasis
0%
Atrial fibrillation
0%
Atrial flutter
0%
Cardiac failure acute
0%
Colonic abscess
0%
Pneumonia
0%
Gallbladder polyp
0%
Chronic sinusitis
0%
This histogram enumerates side effects from a completed 2016 Phase 3 trial (NCT02075255) in the Benra 30 mg q.4 Weeks ARM group. Side effects include: Nasopharyngitis with 15%, Asthma with 8%, Sinusitis with 7%, Headache with 7%, Bronchitis with 7%.

Trial Design

2 Treatment Groups

Benralizumab
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 420 total participants across 2 different treatment groups

This trial involves 2 different treatments. Benralizumab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Benralizumab
Biological
Benralizumab will be administered subcutaneously (SC) using an accessorized prefilled syringe (APFS)
Placebo
Biological
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
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: over 52 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly over 52 weeks for reporting.

Closest Location

Research Site - Denver, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.
Male or female, at least 18 years of age inclusive at the time of signing the ICF
Must have NCFB diagnosed by a physician and confirmed by CT (measured at screening; if a new CT is not possible, a CT performed within 12 months of the screening visit is acceptable).
Documented history of 2 or more bronchiectasis exacerbations within a year of the screening visit.
If receiving prophylactic systemic or inhaled antibiotics to prevent bronchiectasis exacerbations, the dose/regimen must be stable for at least 3 months prior to the screening visit and remain stable throughout the DB period of the study. If prophylactic macrolides have been recently discontinued, patients must have been off treatment for at least 3 months prior to randomisation. In all other cases of prophylactic antibiotic use, ≥ 4 weeks wash out period should be in place after the last dose of antibiotic and prior to randomisation
If receiving inhaled corticosteroid or bronchodilator therapy, the dose and regimen should be stable with no alteration to dose or formulation for at least 3 months prior to the screening visit and this should remain stable throughout the DB period of the study.
Women of childbearing potential (WOCBP) must have a negative serum and urine pregnancy test prior to randomization and agree to use a highly effective method of birth control from enrollment, throughout the study duration, and for 12 weeks after the last dose of IP.

Patient Q&A Section

Can bronchiectasis be cured?

"There is currently no cure for bronchiectasis or a cure that will provide dramatic improvement in quality of life. Treating exacerbating disease features in any manner, including bronchiectasis, is the standard of care. Patients should be encouraged to exercise to make their symptoms subside." - Anonymous Online Contributor

Unverified Answer

What is bronchiectasis?

"Bronchiectasis is a chronic lung disease caused by persistent infections of the airways, secondary to a malfunction or insufficiency of the airway clearance (i.e. mucociliary clearance). In healthy people, mucociliary clearance clears 99.9% of airway surface liquid in 8 hours. This is impaired in bronchiectasis, decreasing the effectiveness of the airway lining membrane to act as a filter for inhaled airborne substances. Bacterial infections are the main cause of bronchiectasis. The chronic cough is a hallmark of bronchiectasis. The underlying disease can be either a congenital or acquired defect." - Anonymous Online Contributor

Unverified Answer

What are the signs of bronchiectasis?

"The main signs of bronchiectasis included night-time dyspnoea, and a decrease in the pulse rate during the day. All suspected patients should report their symptoms back to their doctor." - Anonymous Online Contributor

Unverified Answer

What causes bronchiectasis?

"In this series of patients presenting with bronchiectasis, the most common causes were chronic upper or lower airway obstruction. Bronchiectasis also occurred in conjunction with other health problems." - Anonymous Online Contributor

Unverified Answer

How many people get bronchiectasis a year in the United States?

"Around 14.5 million people in the United States have bronchial bronchiectasis. These diseases will represent over a quarter of people who die under 50. We can do more for these patients than just diagnose them." - Anonymous Online Contributor

Unverified Answer

What are common treatments for bronchiectasis?

"Most patients with bronchiectasis are taking inhaled corticosteroid, such as beclomethasone dipropionate. Inhalers combined with low dose triple therapy can be useful. Inhalers should be used after 6 months of inhaled steroid therapy." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of benralizumab?

"Benralizumab has an acceptable safety profile overall and can be safely administered to patients with idiopathic pulmonary fibrosis in the context of an ongoing clinical trial. Further safety data such as information on its effect on infections are awaited." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving benralizumab?

"Patients with chronic bronchiectasis in whom IFN-alpha-2a or IFN-b was ineffective demonstrated significantly greater improvements in dyspnea when treated with benralizumab. Findings from a recent study are consistent with clinical and preclinical data suggesting that IL-5 inhibitors may potentially benefit patients with chronic obstructive pulmonary disease." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for bronchiectasis?

"The findings of this study have important implications for the treatment and care of patients with bronchiectasis. Although bronchiectasis treatment options are limited, clinical trial information should be given to patients to enable informed decision-making." - Anonymous Online Contributor

Unverified Answer

How serious can bronchiectasis be?

"Bronchiectasis is a very common disease in Latin America and Europe, affecting 3 or 4 million people at any time. In the United States, it occurs about 1 in 750 people, but almost 400 (0.3%) will die. Bronchiectasis can have debilitating effects on daily activity because of shortness of breath, coughing up blood and weight loss. Treatment involves pulmonary rehabilitation. Patients should be identified and screened for the disease, with special attention to lung damage (e.g., pulmonary tuberculosis and COPD). Many of those with bronchiectasis are suffering from debilitating airway obstruction caused by abnormal narrowing of the airways, known as "airway destruction" - this can cause chronic coughing and loss of vital lung function." - Anonymous Online Contributor

Unverified Answer

Has benralizumab proven to be more effective than a placebo?

"The short-term beneficial effect of benralizumab on sputum-producing cells and lung function did not reach a statistical significance by end of week 4, but there was a trend toward a positive effect in those who received the drug. The drug appeared to be more clinically beneficial compared to placebo at 1 month." - Anonymous Online Contributor

Unverified Answer

Is benralizumab typically used in combination with any other treatments?

"The combination of oral antibiotics and an IM MDA with BZ or BZ+RT was found to have a higher cure rate than BZ alone. Benralizumab should be given in combination with antibiotics, such as a cethromycin, but not with corticosteroids." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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