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

NCT ID: NCT05552508

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2024-07-19

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.

Detailed Description

This is a phase IV, interventional single group, open-label, uncontrolled, prospective, multicenter clinical trial.

This study will be conducted in male and female participants ≥18 years old with established severe eosinophilic asthma as defined by European Respiratory Society (ERS)/American Thoracic Society (ATS) clinical guidelines inadequately controlled by treatment with Inhaled Corticosteroids-Long-acting β2 agonists (ICS-LABA) with or without oral corticosteroids (OCS) or other asthma controller medications.

Each participant will participate in the study for a minimum of 15 weeks and up to 23 weeks.

This study will comprise of:

Screening visit (V0) Visit 1 (V1; week 0; within 1 to 21 days of screening) Visit 2 (V2; week 4 ± 5 days) Visit 3 (V3; week 8 ± 5 days) Visit 4 (V4; week 13 ± 5 days) Follow-up (2 weeks [± 7 days] after V4) - Phone call follow-up. Participants will be discharged from the study after the phone call follow-up is completed.

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Benralizumab

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).

Group Type: EXPERIMENTAL

Benralizumab

Intervention Type: COMBINATION_PRODUCT

Participants will receive benralizumab subcutaneously.

Interventions

Benralizumab

Participants will receive benralizumab subcutaneously.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Fasenra

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Walnut Creek, California, United States

Research Site

Loxahatchee Groves, Florida, United States

Research Site

Plantation, Florida, United States

Research Site

Greenwood, Indiana, United States

Research Site

Lexington, Kentucky, United States

Research Site

St Louis, Missouri, United States

Research Site

DuBois, Pennsylvania, United States

Research Site

Tyler, Texas, United States

Research Site

Webster, Texas, United States

Research Site

Charlottesville, Virginia, United States

Research Site

Clayton, , Australia

Research Site

Toorak Gardens, , Australia

Research Site

Liège, , Belgium

Research Site

Namur, , Belgium

Research Site

Montpellier, , France

Research Site

Lisbon, , Portugal

Research Site

Porto, , Portugal

Research Site

Barcelona, , Spain

Research Site

Barcelona, , Spain

Research Site

Barcelona, , Spain

Research Site

Madrid, , Spain

Research Site

Santander, , Spain

Research Site

Villarreal (Castellón), , Spain

Research Site

Bradford, , United Kingdom

Research Site

Nottingham, , United Kingdom

Countries

United States; Australia; Belgium; France; Portugal; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 37131265 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Redacted CSP

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Redacted CSR synopsis

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Redacted SAP

Other Identifiers

2022-000152-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D3250R00107

Identifier Type: -

Identifier Source: org_study_id