RECRUITING

Randomised Clinical Trial to Investigate Efficacy and Safety of Benralizumab 30 mg SC as an add-on Therapy in Uncontrolled Eosinophilic Asthma Patients Treated With Medium-dose ICS-LABA Compared to Conventional Escalation to High-dose ICS-LABA Treatment

Conditions

Eosinophilic Asthma Eosinophilic Asthma;Benralizumab,FASENRA,Medium-Dose Inhaled Corticosteroid,Long-acting β2-Agonist

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA.

Official Title

BRISOTE: A Multicentre, Randomised, Double-Blind, Parallel Group, Active-Controlled, Phase 3b Study to Evaluate the Efficacy and Safety of Benralizumab 30 mg SC in Eosinophilic Asthma Patients Uncontrolled on Medium-Dose Inhaled Corticosteroid Plus Long-acting β2-Agonist.

Quick Facts

Study Start:2025-03-28

Study Completion:2027-11-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06750289

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Written informed consent * Participant must be 12 to 75 years of age * Documented history of physician-diagnosed asthma requiring treatment with at least medium-dose ICS (\> 250 μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit (V) 1. * Documented treatment with medium-dose ICS and LABA for at least 3 months prior to Visit 1 with or without additional asthma controllers (excluding oral corticosteroids). * Weight of ≥ 35 kg. * Pre-Bronchodilator (BD) Forced expiratory volume in 1 second (FEV1) of ≤ 90% predicted * Documented at least 2 asthma exacerbations in the 12 months prior to the date of informed consent. * ACQ-6 score ≥ 1.5 at Visit 1, plus at least once in the run-in period (from V2 to V3) and at V3. * Evidence of asthma as documented by excessive variability in lung function, as defined in the protocol. * Peripheral blood eosinophil count of ≥ 150 cells/μL, as defined in the protocol. * At least 70% compliance with usual asthma controller ICS-LABA during run-in period (from Visit 2 to Visit 3) based on asthma daily diary.	* Important pulmonary disease other than asthma at the discretion of the investigator, or ever been diagnosed with pulmonary or systemic disease, other than asthma, which are associated with elevated peripheral eosinophil counts. * Asthma exacerbation requiring use of Systemic corticosteroids (SCS), or acute upper/lower respiratory infection that requires antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period * Any unstable disorder that in the opinion of the investigator could affect the study according to the study protocol. * Clinically significant chronic or ongoing active infections requiring systemic treatment (at investigator's discretion) * Concurrent participation in another clinical study with an IP or a post-authorisation safety study. * History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained. * Current smokers or former smokers with a smoking history ≥ 10 pack-years. Former smokers must have stopped for at least 6 months prior to Visit 1 to be eligible.

Inclusion Criteria

Exclusion Criteria

* Written informed consent
* Participant must be 12 to 75 years of age
* Documented history of physician-diagnosed asthma requiring treatment with at least medium-dose ICS (\> 250 μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit (V) 1.
* Documented treatment with medium-dose ICS and LABA for at least 3 months prior to Visit 1 with or without additional asthma controllers (excluding oral corticosteroids).
* Weight of ≥ 35 kg.
* Pre-Bronchodilator (BD) Forced expiratory volume in 1 second (FEV1) of ≤ 90% predicted
* Documented at least 2 asthma exacerbations in the 12 months prior to the date of informed consent.
* ACQ-6 score ≥ 1.5 at Visit 1, plus at least once in the run-in period (from V2 to V3) and at V3.
* Evidence of asthma as documented by excessive variability in lung function, as defined in the protocol.
* Peripheral blood eosinophil count of ≥ 150 cells/μL, as defined in the protocol.
* At least 70% compliance with usual asthma controller ICS-LABA during run-in period (from Visit 2 to Visit 3) based on asthma daily diary.

* Important pulmonary disease other than asthma at the discretion of the investigator, or ever been diagnosed with pulmonary or systemic disease, other than asthma, which are associated with elevated peripheral eosinophil counts.
* Asthma exacerbation requiring use of Systemic corticosteroids (SCS), or acute upper/lower respiratory infection that requires antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
* Any unstable disorder that in the opinion of the investigator could affect the study according to the study protocol.
* Clinically significant chronic or ongoing active infections requiring systemic treatment (at investigator's discretion)
* Concurrent participation in another clinical study with an IP or a post-authorisation safety study.
* History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.
* Current smokers or former smokers with a smoking history ≥ 10 pack-years. Former smokers must have stopped for at least 6 months prior to Visit 1 to be eligible.

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479

information.center@astrazeneca.com

Principal Investigator

Sandeep Bansal, MD

PRINCIPAL_INVESTIGATOR

Clinical Research Associates of Central PA

Muhammad Salim, MD

PRINCIPAL_INVESTIGATOR

Chandler Clinical Trials

Jose Diaz, MD

PRINCIPAL_INVESTIGATOR

Flourish Research - Leesburg

Ryan Klein, MD

PRINCIPAL_INVESTIGATOR

NewportNativeMD, Inc.

Rohit Katial, MD

PRINCIPAL_INVESTIGATOR

National Jewish Health

Vikas Sayal, MD

PRINCIPAL_INVESTIGATOR

Henderson Clinical Trials, LLC

Jeremy Cole, MD

PRINCIPAL_INVESTIGATOR

IPS Research Company

Shahrukh Kureishy, MD

PRINCIPAL_INVESTIGATOR

Metroplex Pulmonary and Sleep Center

John Zwetchkenbaum, MD

PRINCIPAL_INVESTIGATOR

Aapri Clinical Research Institute

Erika Gonzalez, MD

PRINCIPAL_INVESTIGATOR

South Texas Allergy & Asthma Medical Professionals (STAAMP)

Sady Alpizar, MD

PRINCIPAL_INVESTIGATOR

Clinical Research Trials of Florida, Inc.

Mila Leong, MD

PRINCIPAL_INVESTIGATOR

Pediatric Pulmonary & Asthma Associates of South Jersey, LLC

Alfonso Gonzalez-Rodriguez, MD

PRINCIPAL_INVESTIGATOR

Florida Premier Research Institute - Clay Street

Njira Lugogo, MD

PRINCIPAL_INVESTIGATOR

University of Michigan Health System - A. Alfred Taubman Health Care Center - Pulmonary Clinic

Samuel DeLeon, MD

PRINCIPAL_INVESTIGATOR

Urban Health Plan

Juan Rodriguez, MD

PRINCIPAL_INVESTIGATOR

Sun City Clinical Research

Neil Kao, MD

PRINCIPAL_INVESTIGATOR

Allergic Disease & Asthma Center, P.A. (ADAC) - Butler Road Office

Charles Lunn, MD

PRINCIPAL_INVESTIGATOR

Lynn Health Science Institute East

Mina Makaryus, MD

PRINCIPAL_INVESTIGATOR

Northwell Health - Centers for Advanced Medicine

Tzu-Jen Tzao, MD

PRINCIPAL_INVESTIGATOR

Pasadena Clinical Trials

Dena Petersen, MD

PRINCIPAL_INVESTIGATOR

Noble Clinical Research - Elite Clinical Network

Patel Paryus, MD

PRINCIPAL_INVESTIGATOR

Prime Healthcare - Inglewood

Marvin Heuer, MD

PRINCIPAL_INVESTIGATOR

Heuer M.D. Research, Inc.

Study Locations (Sites)

Research Site

Chandler, Arizona, 85224

United States

Research Site

Sun City, Arizona, 85351

United States

Research Site

Tucson, Arizona, 85704

United States

Research Site

Inglewood, California, 90301

United States

Research Site

Newport Beach, California, 92663

United States

Research Site

Pasadena, California, 91101

United States

Research Site

Denver, Colorado, 80206

United States

Research Site

Lauderdale Lakes, Florida, 33313

United States

Research Site

Leesburg, Florida, 34748

United States

Research Site

Orlando, Florida, 32819

United States

Research Site

Tampa, Florida, 33607

United States

Research Site

Winter Park, Florida, 32789

United States

Research Site

Ann Arbor, Michigan, 48109

United States

Research Site

Henderson, Nevada, 89052

United States

Research Site

Northfield, New Jersey, 08225

United States

Research Site

Bronx, New York, 10459

United States

Research Site

New Hyde Park, New York, 11042

United States

Research Site

Oklahoma City, Oklahoma, 73111

United States

Research Site

DuBois, Pennsylvania, 15801

United States

Research Site

Warwick, Rhode Island, 02886

United States

Research Site

Greenville, South Carolina, 29607

United States

Research Site

McKinney, Texas, 75069

United States

Research Site

San Antonio, Texas, 78251

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Sandeep Bansal, MD, PRINCIPAL_INVESTIGATOR, Clinical Research Associates of Central PA
Muhammad Salim, MD, PRINCIPAL_INVESTIGATOR, Chandler Clinical Trials
Jose Diaz, MD, PRINCIPAL_INVESTIGATOR, Flourish Research - Leesburg
Ryan Klein, MD, PRINCIPAL_INVESTIGATOR, NewportNativeMD, Inc.
Rohit Katial, MD, PRINCIPAL_INVESTIGATOR, National Jewish Health
Vikas Sayal, MD, PRINCIPAL_INVESTIGATOR, Henderson Clinical Trials, LLC
Jeremy Cole, MD, PRINCIPAL_INVESTIGATOR, IPS Research Company
Shahrukh Kureishy, MD, PRINCIPAL_INVESTIGATOR, Metroplex Pulmonary and Sleep Center
John Zwetchkenbaum, MD, PRINCIPAL_INVESTIGATOR, Aapri Clinical Research Institute
Erika Gonzalez, MD, PRINCIPAL_INVESTIGATOR, South Texas Allergy & Asthma Medical Professionals (STAAMP)
Sady Alpizar, MD, PRINCIPAL_INVESTIGATOR, Clinical Research Trials of Florida, Inc.
Mila Leong, MD, PRINCIPAL_INVESTIGATOR, Pediatric Pulmonary & Asthma Associates of South Jersey, LLC
Alfonso Gonzalez-Rodriguez, MD, PRINCIPAL_INVESTIGATOR, Florida Premier Research Institute - Clay Street
Njira Lugogo, MD, PRINCIPAL_INVESTIGATOR, University of Michigan Health System - A. Alfred Taubman Health Care Center - Pulmonary Clinic
Samuel DeLeon, MD, PRINCIPAL_INVESTIGATOR, Urban Health Plan
Juan Rodriguez, MD, PRINCIPAL_INVESTIGATOR, Sun City Clinical Research
Neil Kao, MD, PRINCIPAL_INVESTIGATOR, Allergic Disease & Asthma Center, P.A. (ADAC) - Butler Road Office
Charles Lunn, MD, PRINCIPAL_INVESTIGATOR, Lynn Health Science Institute East
Mina Makaryus, MD, PRINCIPAL_INVESTIGATOR, Northwell Health - Centers for Advanced Medicine
Tzu-Jen Tzao, MD, PRINCIPAL_INVESTIGATOR, Pasadena Clinical Trials
Dena Petersen, MD, PRINCIPAL_INVESTIGATOR, Noble Clinical Research - Elite Clinical Network
Patel Paryus, MD, PRINCIPAL_INVESTIGATOR, Prime Healthcare - Inglewood
Marvin Heuer, MD, PRINCIPAL_INVESTIGATOR, Heuer M.D. Research, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-28

Study Completion Date2027-11-03

Study Record Updates

Study Start Date2025-03-28

Study Completion Date2027-11-03

Terms related to this study

Keywords Provided by Researchers

Eosinophilic Asthma;
Benralizumab,
FASENRA,
Medium-Dose Inhaled Corticosteroid,
Long-acting β2-Agonist

Additional Relevant MeSH Terms

Eosinophilic Asthma