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

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.

Conditions

Eosinophilic Asthma

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Study Overview

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Study Details

Study overview

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.

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.

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

Condition
Eosinophilic Asthma
Intervention / Treatment

-

Contacts and Locations

Chandler

Research Site, Chandler, Arizona, United States, 85224

Sun City

Research Site, Sun City, Arizona, United States, 85351

Tucson

Research Site, Tucson, Arizona, United States, 85704

Inglewood

Research Site, Inglewood, California, United States, 90301

Newport Beach

Research Site, Newport Beach, California, United States, 92663

Pasadena

Research Site, Pasadena, California, United States, 91101

Denver

Research Site, Denver, Colorado, United States, 80206

Lauderdale Lakes

Research Site, Lauderdale Lakes, Florida, United States, 33313

Leesburg

Research Site, Leesburg, Florida, United States, 34748

Orlando

Research Site, Orlando, Florida, United States, 32819

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

12 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2027-11-03