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New asthma drug could cut attacks for patients not helped by standard inhalers

NCT ID NCT06750289

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether adding benralizumab (an injectable drug) to medium-dose inhalers can reduce asthma attacks in people with eosinophilic asthma whose symptoms are not well controlled. About 400 participants aged 12 to 75 will be randomly assigned to receive benralizumab or a placebo, while both groups continue their usual inhaler. The study compares this approach to the standard step of increasing the inhaler dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
benralizumab
What this could lead to
If successful, this could offer a new add-on treatment option for people with eosinophilic asthma not well controlled on medium-dose inhalers, potentially reducing asthma attacks.
What could go wrong
This is a phase 3 trial, but benralizumab is already approved for severe eosinophilic asthma; this study tests it in a slightly different patient group. It may not show significant benefit over simply increasing inhaler dose, and side effects like allergic reactions are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

pulmonary eosinophilia T2-high asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Eosinophilic asthma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    151 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    WITHDRAWN

    Chandler, Arizona, 85224, United States

  • Research Site

    RECRUITING

    Sun City, Arizona, 85351, United States

  • Research Site

    RECRUITING

    Tucson, Arizona, 85704, United States

  • Research Site

    NOT_YET_RECRUITING

    Bakersfield, California, 93301, United States

  • Research Site

    RECRUITING

    Inglewood, California, 90301, United States

  • Research Site

    NOT_YET_RECRUITING

    Modesto, California, 95355, United States

  • Research Site

    RECRUITING

    Newport Beach, California, 92663, United States

  • Research Site

    RECRUITING

    Pasadena, California, 91101, United States

  • Research Site

    WITHDRAWN

    Denver, Colorado, 80206, United States

  • Research Site

    RECRUITING

    Cape Coral, Florida, 33990, United States

  • Research Site

    NOT_YET_RECRUITING

    Hialeah, Florida, 33015, United States

  • Research Site

    RECRUITING

    Lauderdale Lakes, Florida, 33313, United States

  • Research Site

    RECRUITING

    Leesburg, Florida, 34748, United States

  • Research Site

    NOT_YET_RECRUITING

    Miami, Florida, 33122, United States

  • Research Site

    NOT_YET_RECRUITING

    Miami, Florida, 33155, United States

  • Research Site

    RECRUITING

    Miami, Florida, 33175, United States

  • Research Site

    RECRUITING

    Orlando, Florida, 32819, United States

  • Research Site

    NOT_YET_RECRUITING

    Plantation, Florida, 33324, United States

  • Research Site

    RECRUITING

    Tampa, Florida, 33607, United States

  • Research Site

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Research Site

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    RECRUITING

    Henderson, Nevada, 89052, United States

  • Research Site

    RECRUITING

    Northfield, New Jersey, 08225, United States

  • Research Site

    NOT_YET_RECRUITING

    Union City, New Jersey, 07087, United States

  • Research Site

    RECRUITING

    New Hyde Park, New York, 11042, United States

  • Research Site

    RECRUITING

    The Bronx, New York, 10459, United States

  • Research Site

    WITHDRAWN

    Oklahoma City, Oklahoma, 73103, United States

  • Research Site

    RECRUITING

    Oklahoma City, Oklahoma, 73111, United States

  • Research Site

    RECRUITING

    DuBois, Pennsylvania, 15801, United States

  • Research Site

    RECRUITING

    Warwick, Rhode Island, 02886, United States

  • Research Site

    RECRUITING

    Greenville, South Carolina, 29607, United States

  • Research Site

    NOT_YET_RECRUITING

    Houston, Texas, 77099, United States

  • Research Site

    RECRUITING

    McKinney, Texas, 75069, United States

  • Research Site

    RECRUITING

    San Antonio, Texas, 78251, United States

  • Research Site

    NOT_YET_RECRUITING

    Dimitrovgrad, 6400, Bulgaria

  • Research Site

    NOT_YET_RECRUITING

    Haskovo, 6300, Bulgaria

  • Research Site

    NOT_YET_RECRUITING

    Pleven, 5800, Bulgaria

  • Research Site

    RECRUITING

    Plovdiv, 4002, Bulgaria

  • Research Site

    NOT_YET_RECRUITING

    Plovdiv, 4023, Bulgaria

  • Research Site

    RECRUITING

    Rousse, 7002, Bulgaria

  • Research Site

    RECRUITING

    Sofia, 1142, Bulgaria

  • Research Site

    RECRUITING

    Sofia, 1431, Bulgaria

  • Research Site

    RECRUITING

    Stara Zagora, 6000, Bulgaria

  • Research Site

    NOT_YET_RECRUITING

    Stara Zagora, 6000, Bulgaria

  • Research Site

    WITHDRAWN

    Edmonton, Alberta, T6G 2C8, Canada

  • Research Site

    RECRUITING

    Kamloops, British Columbia, V2C 5T1, Canada

  • Research Site

    RECRUITING

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Research Site

    RECRUITING

    Ajax, Ontario, L1S 2J5, Canada

  • Research Site

    RECRUITING

    Toronto, Ontario, M5T 3A9, Canada

  • Research Site

    RECRUITING

    Windsor, Ontario, N8X 1T3, Canada

  • Research Site

    RECRUITING

    Québec, Quebec, G1G 3Y8, Canada

  • Research Site

    RECRUITING

    Sainte-Foy, Quebec, G1V 4G5, Canada

  • Research Site

    RECRUITING

    Beijing, 100020, China

  • Research Site

    RECRUITING

    Beijing, 100044, China

  • Research Site

    RECRUITING

    Beijing, 102218, China

  • Research Site

    RECRUITING

    Changsha, 410004, China

  • Research Site

    RECRUITING

    Chongqing, 400042, China

  • Research Site

    NOT_YET_RECRUITING

    Fuzhou, 350001, China

  • Research Site

    NOT_YET_RECRUITING

    Fuzhou, 350005, China

  • Research Site

    RECRUITING

    Fuzhou, 350008, China

  • Research Site

    RECRUITING

    Guangzhou, 510120, China

  • Research Site

    RECRUITING

    Guangzhou, 510180, China

  • Research Site

    RECRUITING

    Hangzhou, 31000, China

  • Research Site

    RECRUITING

    Hangzhou, 310014, China

  • Research Site

    RECRUITING

    Hefei, 230061, China

  • Research Site

    RECRUITING

    Huizhou, 516002, China

  • Research Site

    RECRUITING

    Jinan, 250021, China

  • Research Site

    NOT_YET_RECRUITING

    Linyi, 276100, China

  • Research Site

    RECRUITING

    Ningbo, 315020, China

  • Research Site

    RECRUITING

    Qinhuangdao, China

  • Research Site

    RECRUITING

    Shanghai, 200080, China

  • Research Site

    RECRUITING

    Shanghai, 200433, China

  • Research Site

    RECRUITING

    Wenzhou, 325027, China

  • Research Site

    RECRUITING

    Wuhan, 430030, China

  • Research Site

    RECRUITING

    Xuzhou, 221000, China

  • Research Site

    RECRUITING

    Yinchuan, 750004, China

  • Research Site

    RECRUITING

    Zhengzhou, 450000, China

  • Research Site

    RECRUITING

    Bayonne, 64109, France

  • Research Site

    RECRUITING

    Créteil, 94010, France

  • Research Site

    RECRUITING

    La Tronche, 38043, France

  • Research Site

    RECRUITING

    Lyon, 69317, France

  • Research Site

    RECRUITING

    Montpellier, 34295, France

  • Research Site

    RECRUITING

    Pessac, F-33604, France

  • Research Site

    RECRUITING

    Suresnes, 92150, France

  • Research Site

    RECRUITING

    Toulouse, 31059, France

  • Research Site

    RECRUITING

    Villeurbanne, 69100, France

  • Research Site

    RECRUITING

    Berlin, 10367, Germany

  • Research Site

    RECRUITING

    Berlin, 10717, Germany

  • Research Site

    NOT_YET_RECRUITING

    Bonn, 53119, Germany

  • Research Site

    RECRUITING

    Cottbus, 03050, Germany

  • Research Site

    WITHDRAWN

    Delitzsch, 4509, Germany

  • Research Site

    NOT_YET_RECRUITING

    Frankfurt am Main, 60389, Germany

  • Research Site

    RECRUITING

    Geesthacht, 21502, Germany

  • Research Site

    NOT_YET_RECRUITING

    Hemer, 58675, Germany

  • Research Site

    NOT_YET_RECRUITING

    Landsberg, 86899, Germany

  • Research Site

    NOT_YET_RECRUITING

    Langen, 63225, Germany

  • Research Site

    RECRUITING

    Lübeck, 23552, Germany

  • Research Site

    NOT_YET_RECRUITING

    Mönchengladbach, 41063, Germany

  • Research Site

    SUSPENDED

    München, 81377, Germany

  • Research Site

    NOT_YET_RECRUITING

    München-Pasing, 81241, Germany

  • Research Site

    NOT_YET_RECRUITING

    Neu-Isenburg, 63263, Germany

  • Research Site

    RECRUITING

    Wiesbaden, 65183, Germany

  • Research Site

    NOT_YET_RECRUITING

    Witten, 58452, Germany

  • Research Site

    NOT_YET_RECRUITING

    Zossen, 15806, Germany

  • Research Site

    WITHDRAWN

    Hong Kong, 999077, Hong Kong

  • Research Site

    RECRUITING

    Pok Fu Lam, 999077, Hong Kong

  • Research Site

    RECRUITING

    Shatin, 0000, Hong Kong

  • Research Site

    RECRUITING

    Ballinasloe, H53 T971, Ireland

  • Research Site

    RECRUITING

    Cork, T12 DFK4, Ireland

  • Research Site

    RECRUITING

    Dublin, D15 X40D, Ireland

  • Research Site

    RECRUITING

    Moneymore, A92 VW28, Ireland

  • Research Site

    NOT_YET_RECRUITING

    Bari, 70124, Italy

  • Research Site

    RECRUITING

    Bergamo, 24127, Italy

  • Research Site

    RECRUITING

    Brescia, 25123, Italy

  • Research Site

    RECRUITING

    Cagliari, 09122, Italy

  • Research Site

    RECRUITING

    Catanzaro, 88100, Italy

  • Research Site

    RECRUITING

    Genoa, 16132, Italy

  • Research Site

    RECRUITING

    Milan, 20122, Italy

  • Research Site

    WITHDRAWN

    Modena, 41124, Italy

  • Research Site

    RECRUITING

    Montebelluna, 31044, Italy

  • Research Site

    RECRUITING

    Naples, 80131, Italy

  • Research Site

    RECRUITING

    Roma, 00161, Italy

  • Research Site

    RECRUITING

    Roma, 00168, Italy

  • Research Site

    RECRUITING

    Rozzano, 20089, Italy

  • Research Site

    RECRUITING

    Verona, 37124, Italy

  • Research Site

    RECRUITING

    Lørenskog, N-1478, Norway

  • Research Site

    RECRUITING

    Alcorcón, 28922, Spain

  • Research Site

    RECRUITING

    Alzira (Valencia), 46600, Spain

  • Research Site

    RECRUITING

    Badalona, 08916, Spain

  • Research Site

    RECRUITING

    Barakaldo, 48902, Spain

  • Research Site

    RECRUITING

    Barcelona, 08025, Spain

  • Research Site

    RECRUITING

    Barcelona, 08035, Spain

  • Research Site

    RECRUITING

    Burgos, 09006, Spain

  • Research Site

    RECRUITING

    Cáceres, 10003, Spain

  • Research Site

    RECRUITING

    Granada, 18014, Spain

  • Research Site

    RECRUITING

    Jerez de la Frontera, 11407, Spain

  • Research Site

    RECRUITING

    Lugo, 27003, Spain

  • Research Site

    RECRUITING

    Madrid, 28034, Spain

  • Research Site

    RECRUITING

    Madrid, 28041, Spain

  • Research Site

    NOT_YET_RECRUITING

    Madrid, 28050, Spain

  • Research Site

    RECRUITING

    Marbella, 29600, Spain

  • Research Site

    RECRUITING

    Marbella, 29603, Spain

  • Research Site

    RECRUITING

    Málaga, 29010, Spain

  • Research Site

    RECRUITING

    Mérida, 06800, Spain

  • Research Site

    RECRUITING

    Palma de Mallorca, 7120, Spain

  • Research Site

    RECRUITING

    Santander, 39008, Spain

  • Research Site

    RECRUITING

    Aarau, 5001, Switzerland

  • Research Site

    RECRUITING

    Basel, 4031, Switzerland

  • Research Site

    RECRUITING

    Lausanne, 1011, Switzerland

  • Research Site

    RECRUITING

    Sankt Gallen, 9007, Switzerland

  • Research Site

    RECRUITING

    Sion, 1951, Switzerland

  • Research Site

    RECRUITING

    Belfast, BT9 7AB, United Kingdom

  • Research Site

    RECRUITING

    Birmingham, B9 5SS, United Kingdom

  • Research Site

    RECRUITING

    Bradford, BD9 6RJ, United Kingdom

  • Research Site

    RECRUITING

    Bristol, BS10 5NB, United Kingdom

  • Research Site

    RECRUITING

    Chorley, PR7 1PP, United Kingdom

  • Research Site

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • Research Site

    NOT_YET_RECRUITING

    Liverpool, L7 8XP, United Kingdom

  • Research Site

    WITHDRAWN

    Nottingham, NG7 2UH, United Kingdom

  • Research Site

    WITHDRAWN

    Portsmouth, PO6 3LY, United Kingdom

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