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NCT06750289RECRUITINGIRB Ready

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)

Sponsored by AstraZeneca

Quick Self-Assessment

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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

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 ฮผg 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 โ‰ฅ 35 kg.
Pre-Bronchodilator (BD) Forced expiratory volume in 1 second (FEV1) of โ‰ค 90% predicted
Documented at least 2 asthma exacerbations in the 12 months prior to the date of informed consent.
ACQ-6 score โ‰ฅ 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 โ‰ฅ 150 cells/ฮผL, as defined in the protocol.

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

400 participants

๐ŸŽ‚

Age Range

12 Years - 75 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

AstraZeneca

Study Locations

Choose your preferred location or select flexible during enrollment

WITHDRAWN

Chandler

Arizona

Location available
View Chandler location page
NOT_YET_RECRUITING

Sun City

Arizona

Location available
View Sun City location page
RECRUITING

Tucson

Arizona

Location available
View Tucson location page
NOT_YET_RECRUITING

Bakersfield

California

Location available
View Bakersfield location page
RECRUITING

Inglewood

California

Location available
View Inglewood location page
RECRUITING

Newport Beach

California

Location available
View Newport Beach location page
RECRUITING

Pasadena

California

Location available
View Pasadena location page
NOT_YET_RECRUITING

Denver

Colorado

Location available
View Denver location page
RECRUITING

Cape Coral

Florida

Location available
View Cape Coral location page

๐Ÿ“ And 19 more locations available

Frequently Asked Questions

Q: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.

Q: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.

Q: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.

Q: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.

Q: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.

Q: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.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Eosinophilic Asthma Treatment in Chandler?

Join others in Arizona exploring innovative treatment options through clinical research

Eosinophilic Asthma Treatment Options in Chandler, Arizona

If you're searching for Eosinophilic Asthma treatment in Chandler, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Chandler, Sun City, Tucson and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Eosinophilic Asthma. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 400 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Eosinophilic Asthma?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Eosinophilic Asthma

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Eosinophilic Asthma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06750289. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.