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New asthma drug could help kids breathe easier

NCT ID NCT06023589

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 21, 2026 · Updated 6 times

Summary

This study tests whether tezepelumab, an injectable drug, can reduce severe asthma attacks in children aged 5 to 11 with hard-to-control asthma. About 231 kids will receive either tezepelumab or a placebo, alongside their usual asthma medicines. The main goal is to see if the drug lowers the number of serious flare-ups and improves lung function.

What this could mean

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

Active substance
tezepelumab
What this could lead to
If it works, this could give children with severe asthma a new option to prevent serious attacks and improve breathing.
What could go wrong
This is a Phase 3 trial, but results may not apply to all children. Tezepelumab is not a cure; children will still need ongoing asthma management.

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 231 people

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

Started

Aug 2023

Expected to finish

Aug 2030

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

5 to 11 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: 1. Written informed consent from (ICF) at least one parent/caregiver (as per local guidelines) and accompanying informed assent from the participant (where the participant is able to provide assent) prior to admission to the study. 2. Participants must be 5 to \< 12 years of age, at the time of signing the assent form (as applicable per local guidelines) and their caregivers signing the ICF and at Visit 3. 3. Documented physician diagnosis of severe asthma confirmed and evaluated for at least 6 months prior to Visit 1. 4. Documented physician-prescribed treatment with a total daily dose of either medium or high dose, for at least 3 months with stable dose ≥ 1 month prior to Visit 1. 5. Documented treatment with at least one additional maintenance asthma controller medication is required according to local guidelines and standard of care; (long-acting beta agonist, leukotriene receptor antagonist, long-acting muscarinic antagonist) for at least 3 months with stable dose ≥ 1 month prior to Visit 1. 6. Supportive evidence of asthma as documented by one of the following: 1. Post-BD (albuterol/salbutamol) responsiveness of FEV1 ≥ 10% during Screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol with a maximum of 12 puffs of reliever medication only if tolerated by the participant) at either Visit 1 or Visit 2. If (a) is not achieved at Visit 1 or Visit 2, historical documentation by any of the below prior to Visit 1: 2. Post-BD responsiveness of FEV1 ≥ 10%. 3. Positive methacholine challenge defined as provocative concentration (PC20) of ≤ 16 mg/mL. 4. PEF average daily diurnal variability \> 13% over a 2-week period. 5. Variability of FEV1 ≥ 12% between any two clinical visits. 6. Positive exercise challenge test (defined as a fall in FEV1 of \> 12%). 7. FeNO ≥ 20 ppb despite confirmed ICS maintenance therapy. 7. History of at least 2 severe asthma exacerbation events OR 1 severe asthma exacerbation event resulting in hospitalisation within 12 months prior to Visit 1. 8. Pre-BD FEV1 \>50% and ≤ 95%PN OR FEV1/forced vital capacity (FVC) ratio ≤ 0.85 at either Visit 1 or Visit 2. 9. Evidence of uncontrolled asthma, with at least 1 of the below criteria: 1. ACQ-IA score ≥ 1.5 at least once during Screening/Run-in, including Visit 3 (prior to Randomisation) for participants ≥ 6 years old at Screening. 2. Use of reliever medication, other than as a preventive for exercise induced bronchospasm, on 3 or more days per week for at least 1 week during the Screening/Run-in period. 3. Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening/Run-in period. 4. Asthma symptoms 3 or more days per week in at least 1 week during the Screening/Run-in period. 10. Body weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation). Exclusion Criteria: 1. History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis. 2. History of any clinically significant disease or disorder other than asthma which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study. 3. History of a clinically significant deterioration in asthma or asthma exacerbation including those requiring use of systemic corticosteroids or increase in the maintenance dose of oral corticosteroids within 30 days prior to Visit 1. 4. Change in ICS dose within 1 month prior to Visit 1. 5. History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation.

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Conditions

The condition(s) this trial relates to.

asthma chronic asthma

As listed by the trial registrant

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

Asthma

How to take part

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

  1. The places running it

    125 sites in 21 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

    RECRUITING

    Montgomery, Alabama, 36106, United States

  • Research Site

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Research Site

    WITHDRAWN

    Little Rock, Arkansas, 72202, United States

  • Research Site

    RECRUITING

    La Jolla, California, 92037, United States

  • Research Site

    RECRUITING

    Long Beach, California, 90806, United States

  • Research Site

    WITHDRAWN

    Orange, California, 92868, United States

  • Research Site

    RECRUITING

    San Diego, California, 92123, United States

  • Research Site

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Research Site

    TERMINATED

    Savannah, Georgia, 31406, United States

  • Research Site

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Research Site

    TERMINATED

    Ann Arbor, Michigan, 48105, United States

  • Research Site

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Research Site

    RECRUITING

    Northfield, New Jersey, 08225, United States

  • Research Site

    RECRUITING

    Hawthorne, New York, 10532, United States

  • Research Site

    WITHDRAWN

    Schenectady, New York, 12304, United States

  • Research Site

    RECRUITING

    Staten Island, New York, 10305, United States

  • Research Site

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • Research Site

    RECRUITING

    Cincinnati, Ohio, 45229-3039, United States

  • Research Site

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Research Site

    RECRUITING

    Toledo, Ohio, 43617, United States

  • Research Site

    RECRUITING

    Oklahoma City, Oklahoma, 73120, United States

  • Research Site

    WITHDRAWN

    Columbia, South Carolina, 29203, United States

  • Research Site

    TERMINATED

    Coppell, Texas, 75019, United States

  • Research Site

    RECRUITING

    Dallas, Texas, 75246, United States

  • Research Site

    WITHDRAWN

    Frisco, Texas, 75034, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    RECRUITING

    San Antonio, Texas, 78249, United States

  • Research Site

    WITHDRAWN

    Temple, Texas, 76508, United States

  • Research Site

    RECRUITING

    Buenos Aires, 1426, Argentina

  • Research Site

    RECRUITING

    Buenos Aires, C1121ABE, Argentina

  • Research Site

    RECRUITING

    Buenos Aires, C1122, Argentina

  • Research Site

    TERMINATED

    CABA, C1028AAP, Argentina

  • Research Site

    RECRUITING

    Florida, B1602DQD, Argentina

  • Research Site

    RECRUITING

    Lanus, B1824KAJ, Argentina

  • Research Site

    RECRUITING

    Lobos, 7240, Argentina

  • Research Site

    RECRUITING

    Mendoza, M5500CCG, Argentina

  • Research Site

    TERMINATED

    Quilmes, B1878FNR, Argentina

  • Research Site

    RECRUITING

    Rosario, 2000, Argentina

  • Research Site

    RECRUITING

    Blumenau, 89030-101, Brazil

  • Research Site

    RECRUITING

    Curitiba, 80060-240, Brazil

  • Research Site

    WITHDRAWN

    Salvador, 40060-330, Brazil

  • Research Site

    RECRUITING

    São Paulo, 01227-200, Brazil

  • Research Site

    RECRUITING

    São Paulo, 04024-002, Brazil

  • Research Site

    RECRUITING

    São Paulo, 05430-010, Brazil

  • Research Site

    RECRUITING

    Sorocaba, 18040-425, Brazil

  • Research Site

    RECRUITING

    Edmonton, Alberta, T6G 1C9, Canada

  • Research Site

    RECRUITING

    Burlington, Ontario, L7L 6W6, Canada

  • Research Site

    RECRUITING

    Hamilton, Ontario, L8S 1G5, Canada

  • Research Site

    RECRUITING

    Windsor, Ontario, N8X 2G1, Canada

  • Research Site

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Research Site

    RECRUITING

    Beijing, 100191, China

  • Research Site

    RECRUITING

    Changchun, 130021, China

  • Research Site

    NOT_YET_RECRUITING

    Hohhot, 010050, China

  • Research Site

    RECRUITING

    Lanzhou, 730000, China

  • Research Site

    RECRUITING

    Nanjing, 210008, China

  • Research Site

    RECRUITING

    Shanghai, 200062, China

  • Research Site

    WITHDRAWN

    Shanghai, 200127, China

  • Research Site

    RECRUITING

    Shenyang, 110004, China

  • Research Site

    RECRUITING

    Shenzhen, 518026, China

  • Research Site

    NOT_YET_RECRUITING

    Tianjin, 300201, China

  • Research Site

    RECRUITING

    Wuxi, 214023, China

  • Research Site

    NOT_YET_RECRUITING

    Zhanjiang, 524001, China

  • Research Site

    NOT_YET_RECRUITING

    Zhongshan, 528400, China

  • Research Site

    WITHDRAWN

    Bogotá, 110231, Colombia

  • Research Site

    WITHDRAWN

    Bogotá, Colombia

  • Research Site

    WITHDRAWN

    Medellín, 050034, Colombia

  • Research Site

    RECRUITING

    Brest, 29609, France

  • Research Site

    SUSPENDED

    Bron, 69500, France

  • Research Site

    RECRUITING

    Créteil, 94010, France

  • Research Site

    RECRUITING

    Marseille, 13005, France

  • Research Site

    RECRUITING

    Paris, 75012, France

  • Research Site

    RECRUITING

    Paris, 75015, France

  • Research Site

    RECRUITING

    Paris, 75019, France

  • Research Site

    RECRUITING

    Rouen, 76031, France

  • Research Site

    RECRUITING

    Vandœuvre-lès-Nancy, 54511, France

  • Research Site

    RECRUITING

    Debrecen, 4031, Hungary

  • Research Site

    RECRUITING

    Szeged, 6720, Hungary

  • Research Site

    RECRUITING

    Szigetvár, 7900, Hungary

  • Research Site

    RECRUITING

    Genova, 16147, Italy

  • Research Site

    RECRUITING

    Pavia, 27100, Italy

  • Research Site

    NOT_YET_RECRUITING

    Roma, 00165, Italy

  • Research Site

    RECRUITING

    Fukuoka, 811-1394, Japan

  • Research Site

    RECRUITING

    Fukuoka, 813-0017, Japan

  • Research Site

    RECRUITING

    Fukuyama, 720-8520, Japan

  • Research Site

    RECRUITING

    Funabashi-shi, 273-8588, Japan

  • Research Site

    RECRUITING

    Nara, 630-8581, Japan

  • Research Site

    RECRUITING

    Odawara, 250-0055, Japan

  • Research Site

    RECRUITING

    Ōtsu, 520-0804, Japan

  • Research Site

    RECRUITING

    Saga, 840-8571, Japan

  • Research Site

    RECRUITING

    Shimotsuga-gun, 321-0293, Japan

  • Research Site

    WITHDRAWN

    Yokohama, 223-0059, Japan

  • Research Site

    RECRUITING

    Chihuahua City, 31000, Mexico

  • Research Site

    RECRUITING

    Guadalajara, 44100, Mexico

  • Research Site

    NOT_YET_RECRUITING

    Mexico City, 06100, Mexico

  • Research Site

    RECRUITING

    Veracruz, 91910, Mexico

  • Research Site

    RECRUITING

    Amsterdam, 1105 AZ, Netherlands

  • Research Site

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Research Site

    RECRUITING

    Iloilo City, 5000, Philippines

  • Research Site

    RECRUITING

    Las Piñas, 1740, Philippines

  • Research Site

    RECRUITING

    Quezon, 1100, Philippines

  • Research Site

    RECRUITING

    Santa Rosa, 4026, Philippines

  • Research Site

    RECRUITING

    Lodz, 90-329, Poland

  • Research Site

    RECRUITING

    Tarnów, 33-100, Poland

  • Research Site

    RECRUITING

    Bucharest, 020395, Romania

  • Research Site

    RECRUITING

    Bucharest, 050159, Romania

  • Research Site

    RECRUITING

    Bellville, 7531, South Africa

  • Research Site

    RECRUITING

    Cape Town, 7925, South Africa

  • Research Site

    ACTIVE_NOT_RECRUITING

    Durban, 3630, South Africa

  • Research Site

    RECRUITING

    Durban, 4001, South Africa

  • Research Site

    RECRUITING

    Middelburg, 1055, South Africa

  • Research Site

    WITHDRAWN

    Thabazimbi, 0380, South Africa

  • Research Site

    RECRUITING

    Vereeniging, 1935, South Africa

  • Research Site

    RECRUITING

    Welkom, 9460, South Africa

  • Research Site

    WITHDRAWN

    Seongnam-si, 13496, South Korea

  • Research Site

    RECRUITING

    Seongnam-si, 13620, South Korea

  • Research Site

    RECRUITING

    Seoul, 03181, South Korea

  • Research Site

    RECRUITING

    Seoul, 03722, South Korea

  • Research Site

    RECRUITING

    Badalona, 08916, Spain

  • Research Site

    RECRUITING

    Barcelona, 08035, Spain

  • Research Site

    RECRUITING

    Esplugues de Llobregat (Barc), 08950, Spain

  • Research Site

    RECRUITING

    Madrid, 28009, Spain

  • Research Site

    RECRUITING

    Sabadell, 08208, Spain

  • Research Site

    RECRUITING

    Valencia, 46010, Spain

  • Research Site

    WITHDRAWN

    Valencia, 46026, Spain

  • Research Site

    RECRUITING

    Villarreal, 12540, Spain

  • Research Site

    RECRUITING

    Bangkok, 10330, Thailand

  • Research Site

    RECRUITING

    Bangkoknoi, 10700, Thailand

  • Research Site

    RECRUITING

    Chiang Mai, 50200, Thailand

  • Research Site

    RECRUITING

    Muang, 40002, Thailand

  • Research Site

    RECRUITING

    Bursa, 16059, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Istanbul, 34899, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Izmir, 35210, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Yenimahalle, 06500, Turkey (Türkiye)

  • Research Site

    RECRUITING

    Chernivtsi, 58002, Ukraine

  • Research Site

    RECRUITING

    Ivano-Frankivsk, 76000, Ukraine

  • Research Site

    RECRUITING

    Kyiv, 03038, Ukraine

  • Research Site

    RECRUITING

    Kyiv, 04050, Ukraine

  • Research Site

    RECRUITING

    Birmingham, B4 6NH, United Kingdom

  • Research Site

    RECRUITING

    Bradford, BD9 6RJ, United Kingdom

  • Research Site

    RECRUITING

    Bristol, BS2 8BJ, United Kingdom

  • Research Site

    WITHDRAWN

    Glasgow, G3 8SJ, United Kingdom

  • Research Site

    RECRUITING

    Leicester, LE1 5WW, United Kingdom

  • Research Site

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Research Site

    RECRUITING

    Nottingham, NG7 2UH, United Kingdom

  • Research Site

    RECRUITING

    Stoke-on-Trent, ST4 6QG, United Kingdom

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