BURAN: Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging

NCT05552508 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: D3250R001072022-000152-11
• Study Type: interventional
• Target: 45
• Locations: 7 countries
• Sites: 25

Brief Summary

This study will assess the effects of benralizumab on airway dynamics in severe eosinophilic asthma in terms of quantitative computed tomography (CT)-derived measurements of pulmonary structure and function using the Functional Respiratory Imaging (FRI) platform.

Conditions

Asthma

Keywords

BURAN; Inhaled Corticosteroids; Long-acting β2 agonists; Benralizumab; Eosinophilic Asthma

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Untrimmed Total Mucus Volume at TLC

  Change from baseline in airway dynamics after 13 weeks following treatment with benralizumab, using total mucus volume (specific airway volume) at total lung capacity (TLC) measurements from untrimmed airways was assessed.

  Baseline and Week 13

Secondary Outcomes (36)

• Change From Baseline in Untrimmed Total Mucus Plugs Score at TLC

  Baseline and Week 13

• Change From Baseline in Untrimmed Total Air Trapping at FRC

  Baseline and Week 13

• Change From Baseline in Trimmed Distal Airway Wall Volume at TLC

  Baseline and Week 13

• Change From Baseline in Untrimmed Distal Airway Volume at TLC

  Baseline and Week 13

• Change From Baseline in Untrimmed Distal Airway Volume at Functional Residual Capacity (FRC)

  Baseline and Week 13

Study Arms (1)

Benralizumab

EXPERIMENTAL

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).

Combination Product: Benralizumab

Interventions

Benralizumab COMBINATION_PRODUCT

Participants will receive benralizumab subcutaneously.

Also known as: Fasenra

Benralizumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are diagnosed with asthma with documented reversibility post-bronchodilator or salbutamol either historical or at Visit 0 (V0).
• Participants who have documented treatment with ICS and LABA for ≥ 3 months prior to V0 with or without oral corticosteroids and additional asthma controllers.
• Participants who have documented peripheral blood eosinophil count ≥ 300 cells/μL at V0, or if Oral Corticosteroids (OCS)-dependent, a documented peripheral blood eosinophil count ≥ 150 cells/μL at V0.
• Participants who have had a minimum of 2 exacerbations in the last 12 months prior to V0.
• Participants who have pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) ≤ 70% at Visit 0 (V0).
• Participants who have pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) \< 80% of predicted at V0.
• Participants who can perform acceptable and repeatable spirometry.
• Participants who can withhold asthma maintenance medication for at least 12 hours prior to V0, 1 and 4 where spirometry and/or Computed Tomography (CT) scan procedures will be performed except for once-a-day dosage where 24 hours will be required.
• Female participants who have a negative pregnancy test prior to administration of the investigational product (IP) and high-resolution CT scan and must agree to use a highly effective method of birth control from randomization throughout the study duration and within 12 weeks after last dose of IP.

You may not qualify if:

• Participants who are unstable or who experienced an exacerbation/infection in the 6 weeks before V0.
• Participants with acute upper or lower airway infection in the 6 weeks before V0.
• Participants diagnosed with clinically important pulmonary disease other than asthma, or participants who have ever been diagnosed with pulmonary or systemic disease, other than asthma that are associated with elevated peripheral eosinophil count.
• Receipt of any biologic products for asthma within 4 months or 5 half-lives prior to V0 whichever is longer.
• History or current use of chronic (i.e., \> 4 weeks) immunosuppressive medication.
• History of lung volume reduction surgery, lung resection, thermal bronchoplasty at any time before visit 0 (V0) or on active phase of pulmonary rehabilitation.
• Participants with current malignancy or history of malignancy.
• History of other clinically significant disease or abnormality.
• Participants with positive Hepatitis B, C or HIV.
• Participants with:
• Positive COVID-19 test at V0, COVID-19 disease within 6 weeks before V0 or History of severe COVID-19 disease at any time, defined by the need for Intensive Care Unit stay or Mechanical Ventilation (invasive or non-invasive).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (25)

Research Site

Walnut Creek, California, 94598, United States

Location

Research Site

Loxahatchee Groves, Florida, 33470, United States

Location

Research Site

Plantation, Florida, 33324, United States

Location

Research Site

Greenwood, Indiana, 46143, United States

Location

Research Site

Lexington, Kentucky, 40536, United States

Location

Research Site

St Louis, Missouri, 63110, United States

Location

Research Site

DuBois, Pennsylvania, 15801, United States

Location

Research Site

Tyler, Texas, 75708, United States

Location

Research Site

Webster, Texas, 77598, United States

Location

Research Site

Charlottesville, Virginia, 22908, United States

Location

Research Site

Clayton, 3168, Australia

Location

Research Site

Toorak Gardens, 5065, Australia

Location

Research Site

Liège, 4000, Belgium

Location

Research Site

Namur, 5101, Belgium

Location

Research Site

Montpellier, 34295, France

Location

Research Site

Lisbon, 1649-035, Portugal

Location

Research Site

Porto, 4100-180, Portugal

Location

Research Site

Barcelona, 08006, Spain

Location

Research Site

Barcelona, 08017, Spain

Location

Research Site

Barcelona, 8003, Spain

Location

Research Site

Madrid, 28007, Spain

Location

Research Site

Santander, 39008, Spain

Location

Research Site

Villarreal (Castellón), 12540, Spain

Location

Research Site

Bradford, BND9 6RJ, United Kingdom

Location

Research Site

Nottingham, NG5 1PB, United Kingdom

Location

Related Publications (1)

• Genofre E, Carstens D, DeBacker W, Muchmore P, Panettieri RA Jr, Rhodes K, Shih VH, Trudo F. The effects of benralizumab on airway geometry and dynamics in severe eosinophilic asthma: a single-arm study design exploring a functional respiratory imaging approach. Respir Res. 2023 May 3;24(1):121. doi: 10.1186/s12931-023-02415-4.

  PMID: 37131265 DERIVED

Related Links

• Redacted CSP
• Redacted CSR synopsis
• Redacted SAP

MeSH Terms

Conditions

Asthma; Pulmonary Eosinophilia

Interventions

benralizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: September 23, 2022
• Study Start: October 11, 2022
• Primary Completion: July 19, 2024
• Study Completion: July 19, 2024
• Last Updated: March 25, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

ES (6); FR (1); PT (2); US (10); AU (2); BE (2); GB (2)