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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05552508




Registration number
NCT05552508
Ethics application status
Date submitted
27/04/2022
Date registered
23/09/2022

Titles & IDs
Public title
BURAN: Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging
Scientific title
BURAN: Effects of Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging Parameters
Secondary ID [1] 0 0
2022-000152-11
Secondary ID [2] 0 0
D3250R00107
Universal Trial Number (UTN)
Trial acronym
BURAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Blood 0 0 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Benralizumab

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).


Other interventions: Benralizumab
Participants will receive benralizumab subcutaneously.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in Total Mucus Volume
Timepoint [1] 0 0
Baseline (at week 0), Week 13
Secondary outcome [1] 0 0
Change from baseline in Total mucus plugs score
Timepoint [1] 0 0
Baseline (at week 0), Week 13
Secondary outcome [2] 0 0
Change from baseline in Total air trapping
Timepoint [2] 0 0
Baseline (at week 0), Week 13
Secondary outcome [3] 0 0
Change from baseline in trimmed distal Airway wall volume (iVaww) at TLC
Timepoint [3] 0 0
Baseline (at week 0), Week 13
Secondary outcome [4] 0 0
Change from baseline in distal Specific airway volume (siVaw) at TLC
Timepoint [4] 0 0
Baseline (at week 0), Week 13
Secondary outcome [5] 0 0
Change from baseline in distal Specific airway volume (siVaw) at FRC
Timepoint [5] 0 0
Baseline (at week 0), Week 13
Secondary outcome [6] 0 0
Change from baseline in Total Lung volume (iVlung) at TLC
Timepoint [6] 0 0
Baseline (at week 0), Week 13
Secondary outcome [7] 0 0
Change from baseline in Total Lung volume (iVlung) at FRC
Timepoint [7] 0 0
Baseline (at week 0), Week 13
Secondary outcome [8] 0 0
Correlation between imaging endpoints (Primary and Secondary FRI endpoints) and pre-bronchodilator forced expiratory volume (pre-BD FEV1)
Timepoint [8] 0 0
Baseline (at week 0)
Secondary outcome [9] 0 0
Correlation between imaging endpoints (Primary and Secondary FRI endpoints) and pre-bronchodilator forced vital capacity (pre-BD FVC)
Timepoint [9] 0 0
Baseline (at week 0)
Secondary outcome [10] 0 0
Correlation between the change in imaging endpoints (Primary and Secondary FRI endpoints) and the change in pre-BD FEV1 (± 5 days), overall and within subgroups conditional on the baseline value of pre-BD FEV1
Timepoint [10] 0 0
Baseline (at week 0), Week 13
Secondary outcome [11] 0 0
Correlation between the change in imaging endpoints (Primary and Secondary FRI endpoints) and the change in pre-BD FVC (± 5 days), overall and within subgroups conditional on the baseline value of pre-BD FVC
Timepoint [11] 0 0
Baseline (at week 0), Week 13
Secondary outcome [12] 0 0
Number of patients with Adverse Events (AEs)
Timepoint [12] 0 0
From screening to follow-up (up to 1.9 years)
Secondary outcome [13] 0 0
Change from baseline in Total Mucus Volume at TLC with and without adjustment for pre-BD FEV1
Timepoint [13] 0 0
Baseline (at week 0), Week 13
Secondary outcome [14] 0 0
Change from baseline in Total Mucus Volume at TLC with and without adjustment for pre-BD FVC
Timepoint [14] 0 0
Baseline (at week 0), Week 13
Secondary outcome [15] 0 0
Change from baseline in total air trapping with and without adjustment for pre-BD FEV1
Timepoint [15] 0 0
Baseline (at week 0), Week 13
Secondary outcome [16] 0 0
Change from baseline in total air trapping with and without adjustment for pre-BD FVC
Timepoint [16] 0 0
Baseline (at week 0), Week 13
Secondary outcome [17] 0 0
Change from baseline in trimmed distal iVaww at TLC with and without adjustment for pre-BD FEV1
Timepoint [17] 0 0
Baseline (at week 0), Week 13
Secondary outcome [18] 0 0
Change from baseline in trimmed distal iVaww at TLC with and without adjustment for pre-BD FVC
Timepoint [18] 0 0
Baseline (at week 0), Week 13
Secondary outcome [19] 0 0
Change from baseline in trimmed distal siVaw at TLC with and without adjustment for pre-BD FEV1
Timepoint [19] 0 0
Baseline (at week 0), Week 13
Secondary outcome [20] 0 0
Change from baseline in trimmed distal siVaw at TLC with and without adjustment for pre-BD FVC
Timepoint [20] 0 0
Baseline (at week 0), Week 13
Secondary outcome [21] 0 0
Change from baseline in trimmed distal siVaw at FRC with and without adjustment for pre-BD FEV1
Timepoint [21] 0 0
Baseline (at week 0), Week 13
Secondary outcome [22] 0 0
Change from baseline in trimmed distal siVaw at FRC with and without adjustment for pre-BD FVC
Timepoint [22] 0 0
Baseline (at week 0), Week 13
Secondary outcome [23] 0 0
Change from baseline in total iVlung at TLC with and without adjustment for pre-BD FEV1
Timepoint [23] 0 0
Baseline (at week 0), Week 13
Secondary outcome [24] 0 0
Change from baseline in total iVlung at TLC with and without adjustment for pre-BD FVC
Timepoint [24] 0 0
Baseline (at week 0), Week 13
Secondary outcome [25] 0 0
Change from baseline in total iVlung at FRC with and without adjustment for pre-BD FEV1
Timepoint [25] 0 0
Baseline (at week 0), Week 13
Secondary outcome [26] 0 0
Change from baseline in total iVlung at FRC with and without adjustment for pre-BD FVC
Timepoint [26] 0 0
Baseline (at week 0), Week 13
Secondary outcome [27] 0 0
Change from baseline in total mucus plugs score with and without adjustment for pre-BD FEV1
Timepoint [27] 0 0
Baseline (at week 0), Week 13
Secondary outcome [28] 0 0
Change from baseline in total mucus plugs score with and without adjustment for pre-BD FVC
Timepoint [28] 0 0
Baseline (at week 0), Week 13
Secondary outcome [29] 0 0
Change from baseline in imaging endpoints ( Primary and Secondary FRI endpoints) for every one percent correlation between pre-BD FEV1 and pre-BD FVC
Timepoint [29] 0 0
Week 0, and Week 13

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/07/2024
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Clayton
Recruitment hospital [2] 0 0
Research Site - Toorak Gardens
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
5065 - Toorak Gardens
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Belgium
State/province [9] 0 0
Liege
Country [10] 0 0
Belgium
State/province [10] 0 0
Namur
Country [11] 0 0
France
State/province [11] 0 0
Montpellier Cedex 5
Country [12] 0 0
Portugal
State/province [12] 0 0
Lisboa
Country [13] 0 0
Portugal
State/province [13] 0 0
Porto
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid
Country [16] 0 0
Spain
State/province [16] 0 0
Santander
Country [17] 0 0
Spain
State/province [17] 0 0
Villarreal (Castellón)
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Bradford
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05552508