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Monoclonal Antibodies
Benralizumab for Severe Asthma (BURAN Trial)
Phase 4
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have you been diagnosed with Asthma?
Have had at least two exacerbations within the last 12 months?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening to follow-up (up to 1.4 years)
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will test benralizumab, a medication that reduces inflammation in the airways, on adults with severe eosinophilic asthma not well-controlled by standard treatments. The medication works by lowering the number of specific cells that cause breathing problems. Benralizumab helps improve lung function for patients with severe, uncontrolled asthma with eosinophilic inflammation.
Who is the study for?
This trial is for people with severe eosinophilic asthma who've had at least two flare-ups in the past year. They should be on a stable asthma treatment and able to stop their maintenance medication for 12-24 hours before certain visits. It's not open to those with significant other diseases, a current or past cancer diagnosis, or a history of specific lung procedures.
What is being tested?
The BURAN study is testing how benralizumab affects airway dynamics in patients with severe eosinophilic asthma. Researchers will use advanced imaging (Functional Respiratory Imaging) and CT scans to measure changes in lung structure and function.
What are the potential side effects?
Benralizumab may cause side effects such as headache, sore throat, fever, fatigue, allergic reactions including anaphylaxis, and injection site reactions like pain or swelling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with asthma.
Select...
I have had two or more flare-ups of my condition in the past year.
Select...
My asthma treatment has not changed recently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening to follow-up (up to 1.4 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening to follow-up (up to 1.4 years)
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 in specific airway volume (siVaw)
Secondary study objectives
Change from baseline in Airway resistance (iRaw)
Change from baseline in Airway volume (iVaww)
Change from baseline in BVX with and without adjustment for pre-BD FEV1
+36 moreSide effects data
From 2016 Phase 3 trial • 220 Patients • NCT0207525515%
Nasopharyngitis
8%
Asthma
7%
Sinusitis
7%
Headache
7%
Bronchitis
6%
Upper respiratory tract infection
4%
Influenza
3%
Back pain
3%
Cough
3%
Dyspnoea
3%
Hypertension
3%
Rhinitis
1%
Urosepsis
1%
Nephrolithiasis
1%
Intervertebral disc protrusion
1%
Umbilical hernia
1%
Adverse drug reaction
1%
Hypersensitivity
1%
Vertigo
1%
Nausea
1%
Dermatitis atopic
1%
Urinary tract infection bacterial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benra 30 mg q.4 Weeks
Benra 30 mg q.8 Weeks
Placebo
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: BenralizumabExperimental Treatment1 Intervention
Participants will receive 3 doses of benralizumab having a strength of 30 mg subcutaneously once every 4 weeks (Week 0, Week 4, and Week 8).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benralizumab
2016
Completed Phase 4
~10540
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
Asthma treatments often target the underlying inflammation and bronchoconstriction characteristic of the disease. Common treatments include inhaled corticosteroids (ICS) that reduce airway inflammation, and long-acting beta-agonists (LABA) that relax bronchial muscles to improve airflow.
Biological therapies, such as Benralizumab, target specific pathways involved in asthma. Benralizumab is an anti-IL-5 receptor monoclonal antibody that depletes eosinophils, a type of white blood cell that contributes to airway inflammation and hyper-responsiveness in eosinophilic asthma.
By reducing eosinophil levels, Benralizumab can decrease the frequency of asthma exacerbations and improve lung function. Understanding these mechanisms is crucial for asthma patients as it helps tailor treatments to their specific type of asthma, potentially leading to better disease management and improved quality of life.
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,375 Previous Clinical Trials
288,738,605 Total Patients Enrolled
346 Trials studying Asthma
661,228 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can stop my asthma medication for 12-24 hours before certain tests.I have been diagnosed with asthma.I have had two or more flare-ups of my condition in the past year.My asthma treatment has not changed recently.I have a significant medical condition apart from my current diagnosis.I currently have cancer or have had cancer in the past.I have had surgery to reduce lung volume, remove part of my lung, or thermal bronchoplasty.
Research Study Groups:
This trial has the following groups:- Group 1: Benralizumab
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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