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

Study identifier:D3250R00107

ClinicalTrials.gov identifier:NCT05552508

EudraCT identifier:2022-000152-11

CTIS identifier:N/A

Recruitment Complete

Official Title

BURAN: Effects of Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma using Functional Respiratory Imaging Parameters

Medical condition

asthma

Phase

Phase 4

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 11 Oct 2022

Estimated Primary Completion Date: 31 Jul 2024

Estimated Study Completion Date: 31 Jul 2024

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2024 by AstraZeneca

Collaborators

Inclusion and exclusion 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).

No locations available

Arms	Assigned Interventions
Experimental: 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).	-

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]