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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

BURAN Trial Summary

This trial will study the effects of benralizumab on airway dynamics in people with severe eosinophilic asthma, by measuring changes in pulmonary structure and function using CT scans.

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.Check my eligibility
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.See study design
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.

BURAN Trial Eligibility Criteria

Inclusion Criteria

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

BURAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening to follow-up (up to 1.4 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening to follow-up (up to 1.4 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in specific airway volume (siVaw)
Secondary outcome measures
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 more

Side effects data

From 2016 Phase 3 trial • 220 Patients • NCT02075255
16%
Nasopharyngitis
11%
Bronchitis
8%
Headache
8%
Rhinitis
7%
Upper respiratory tract infection
5%
Sinusitis
4%
Hypertension
4%
Vertigo
3%
Back pain
3%
Pneumonia
1%
Asthma
1%
Cough
1%
Dyspnoea
1%
Cardiac failure acute
1%
Atrial fibrillation
1%
Presyncope
1%
Influenza
1%
Oesophagitis
1%
Gallbladder polyp
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benra 30 mg q.8 Weeks
Benra 30 mg q.4 Weeks
Placebo

BURAN 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 3
~10580

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,265 Previous Clinical Trials
288,605,144 Total Patients Enrolled
328 Trials studying Asthma
639,496 Patients Enrolled for Asthma

Media Library

Benralizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05552508 — Phase 4
Asthma Research Study Groups: Benralizumab
Asthma Clinical Trial 2023: Benralizumab Highlights & Side Effects. Trial Name: NCT05552508 — Phase 4
Benralizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05552508 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research initiative include individuals aged 45 and above?

"To be accepted into this clinical trial, participants must fall within the age range of 18 and 70. Additionally, a total of 114 separate trials are available for minors while 198 can be found targeting patients over 65 years old."

Answered by AI

Has Benralizumab obtained governmental authorization for commercial use?

"There is ample evidence to suggest that Benralizumab is safe, thus the treatment was awarded a 3 on our 1-3 scale. This trial being in Phase 4 also indicates that it has been approved by regulatory bodies."

Answered by AI

To what population is this research experiment open?

"In order to be approved for this clinical trial, individuals must suffer from asthma and possess an age between 18 and 70. The research team is currently looking to enroll roughly 135 participants."

Answered by AI

Are there any vacancies available to enrollees in this experiment?

"This medical trial is actively seeking patients, as confirmed by clinicaltrials.gov. It was first listed on October 11th 2022 and updated the latest time on November 18th 2022."

Answered by AI

What is the upper cap on participants for this clinical experiment?

"Affirmative. Data hosted on clinicaltrials.gov affirms that this medicine trial, which went live on October 11th 2022, is actively enrolling subjects. The study aims to recruit 135 individuals from 9 different medical centres."

Answered by AI

Is the trial being conducted in multiple Canadian healthcare facilities?

"At present, this medical trial is conducted at 9 separate sites situated in Lexington, Loxahatchee Groves and Knoxville as well as other nearby cities. Potential patients should opt for the closest clinic to minimize any necessary travel."

Answered by AI

Who else is applying?

What state do they live in?
California
Tennessee
Other
Texas
What site did they apply to?
Other
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
Recent research and studies
clinicaltrials.govStudy
BURAN: Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging
2022. "BURAN: Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05552508.
~55 spots leftby Apr 2025
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