At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- ICS-LABA (combination product), benralizumab (combination product), Placebo for Benralizumab (combination product)
- How long the study runs
- Study runs about 44 months (dates as stated)
- About the drug or intervention
- ICS-LABA — combination product: ICS-LABA inhalation · benralizumab — combination product: Benralizumab. · Placebo for Benralizumab — combination product: Placebo for Benralizumab (aka, "placebo").
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at whether benralizumab 30 mg, given by injection under the skin, helps people aged 12 to 75 with uncontrolled eosinophilic asthma (a type of asthma linked to high levels of a white blood cell called eosinophils). It compares adding benralizumab to usual treatment with the standard approach of increasing the asthma inhaler dose. The study is funded by AstraZeneca.
Who can take part
- Aged 12 to 75, with written informed consent
- Doctor-diagnosed asthma treated with a medium-dose inhaled corticosteroid (ICS) plus a long-acting bronchodilator (LABA) inhaler for at least 12 months, and on this treatment for at least 3 months before joining
- Weigh at least 35 kg
- Lung function (FEV1, a breathing test) at or below 90% of the predicted level before using an inhaler
- At least 2 asthma flare-ups in the past 12 months
- Asthma symptom score (ACQ-6) of 1.5 or higher showing asthma is not well controlled
- Blood test showing eosinophil count of 150 cells/μL or higher
- Evidence of variable lung function as defined in the study plan
- Took at least 70% of their usual asthma inhaler during the run-in period, based on a daily diary
Who may not be able to
- Another lung condition besides asthma, or any other condition that raises eosinophil levels
- An asthma flare-up needing steroid tablets, or a chest or airway infection needing antibiotics or antiviral medicine, in the 30 days before joining or during screening
- Any unstable health problem that could affect taking part
- Long-term or ongoing infections needing treatment
- Taking part in another clinical trial or a post-authorisation safety study
- Alcohol or drug misuse in the past 12 months
- Current smokers, or former smokers with a history of 10 or more pack-years (former smokers must have quit at least 6 months before joining)
What taking part involves
- • Benralizumab 30 mg given as an injection under the skin, added to your current medium-dose asthma inhaler
- • The comparison group has their usual treatment increased to a high-dose inhaled corticosteroid (ICS) plus long-acting bronchodilator (LABA) inhaler
- • Regular study visits, breathing tests and blood tests as set out in the study plan — details not stated, ask the trial team
Time commitment: Not stated — ask the trial team (a run-in period with a daily asthma diary is mentioned, but the number of visits and total study length are not stated).
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 12 Years to 75 Years
- Who
- All
- Number of participants
- 400
- Started
- 2025-03-28
- Last checked
- 2026-05
Plain English Summary
What is this study?
- • Testing a new treatment for eosinophilic asthma
- • Phase3 - 400 participants
- • 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 take part?
- • Ages 12 Years to 75 Years
- • Diagnosed with eosinophilic asthma
Where?
- • Belfast - Research Site
- • Birmingham - Research Site
- • Bradford - Research Site
- • Bristol - Research Site
- • +5 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This is a randomized, double-blind, active-controlled, parallel group global study designed to investigate the efficacy and safety of adding fixed-dose benralizumab (30 mg), administered subcutaneously (SC) every 4 weeks for the first 3 doses and then every 8 weeks for participants with a history of eosinophilic asthma, who remain uncontrolled on medium-dose Inhaled corticosteroid-Long-acting β2-agonists (ICS-LABA) with or without other asthma controller(s) (with the exception of oral corticosteroids), compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA plus placebo (benralizumab).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 12 Years - 75 Years
- Who can join: All genders
What the study is looking for
- ✓Written agreement to take part
- ✓Participant must be 12 to 75 years of age
- ✓Documented treatment with medium-dose ICS and LABA for at least 3 months prior to Visit 1 with or without additional...
- ✓Weight of ≥ 35 kg.
- ✓Pre-Bronchodilator (BD) Forced expiratory volume in 1 second (FEV1) of ≤ 90% predicted
Who cannot take part
- ✗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 agreement to take part is obtained.
- ✗Current smokers or former smokers with a smoking history ≥ 10 pack-years. Former smokers must have stopped for at...
See the full criteria
Where Is This Study? (9 UK sites)
Research Site
Belfast BT9 7AB, United Kingdom
Research Site
Birmingham B9 5SS, United Kingdom
Research Site
Bradford BD9 6RJ, United Kingdom
Research Site
Bristol BS10 5NB, United Kingdom
Research Site
Chorley PR7 1PP, United Kingdom
Research Site
Leeds LS9 7TF, United Kingdom
Research Site
Liverpool L7 8XP, United Kingdom
Research Site
Nottingham NG7 2UH, United Kingdom
Research Site
Portsmouth PO6 3LY, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
