NCT06750289 · AstraZeneca
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
(BRISOTE)
What this study is about
This study evaluates the effectiveness 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.
View original scientific 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.
Interventions
COMBINATION_PRODUCT
ICS-LABA
ICS-LABA inhalation
COMBINATION_PRODUCT
benralizumab
Benralizumab. SC injection.
COMBINATION_PRODUCT
Placebo for Benralizumab
Placebo for Benralizumab (aka, "placebo"). SC injection.
Primary outcome measures
Annualized asthma exacerbation rate
Time frame: Baseline through Week 48
To assess asthma exacerbation rate.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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.
Exclusion criteria
- 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.
Where
- Sun City, Arizona
- Tucson, Arizona
- Inglewood, California
- Newport Beach, California
- Pasadena, California
- Cape Coral, Florida
- Lauderdale Lakes, Florida
- Leesburg, Florida
- Miami, Florida
- Tampa, Florida
- Winter Park, Florida
- Ann Arbor, Michigan
And 8 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 16, 2026 · Source of record for eligibility and locations