New asthma drug shows promise in early trial

NCT ID NCT06020014

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental inhaled drug called AZD4604 in 339 adults with moderate-to-severe asthma that remains uncontrolled despite standard treatment. Participants took the drug or a placebo twice daily for 12 weeks. The main goal was to see if the drug could reduce asthma worsening events, measured by a combination of symptoms, rescue inhaler use, and lung function. The trial is now complete, but results have not yet been shared.

What this could mean

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

Active substance: AZD4604 (an inhaled drug)
What this could lead to: If it works, this could provide a new inhaled treatment option for people whose asthma is not well controlled with current medications.
What could go wrong: This is an early Phase 2a study with a composite endpoint, not a direct measure of asthma attacks. The drug may not show meaningful benefit or could have side effects. Results are not yet published.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

339 people

The number who actually took part.

Started

Nov 2023

Finished

Oct 2025

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

18 to 80 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. 18 to 80 years of age inclusive, at the time of signing the informed consent. 2. Treated with medium-high dose ICS in combination with LABA at a stable dose for at least 28 days prior to Visit 1. Note: EU participants must be treated with high dose ICS in combination with LABA at a stable dose for at least 28 days prior to V1. 3. Documented history of ≥ 1 severe asthma exacerbation within 1 year prior to Visit 1. 4. Morning pre-BD FEV1 ≥ 40% predicted at Visit 1 and Visit 3. 5. Able to perform acceptable lung function testing for FEV1 according to ATS/ERS 2019 acceptability criteria. 6. Documented evidence of asthma in the 10 years up to or including Visit 1. A clinical diagnosis of asthma must be documented at least 12 months prior to Screening (Visit 1). 7. An ACQ-6 score ≥ 1.5 at Visit 1 and at Visit 3. 9\. Body weight of ≥ 40 kg and body mass index of \< 35 kg/m2. 10. Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. There are no restrictions on male participants or their female partners At the end of the Run-in period (Visit 3), participants must fulfil the following additional criteria in order to be randomised into the study and enter the Treatment period: 1. Pre-BD FEV1 ≥ 40%. 2. A pre-BD/pre-IMP dose FEV1 at Visit 3 that has not increased or decreased by 20% or more from the pre-BD FEV1 recorded at Visit 1 and at Visit 2. 3. An ACQ-6 score of ≥ 1.5. 4. At least 80% compliance with usual asthma background medication during Run-in period (from Visit 2 to Visit 3) based on the daily asthma ePROs. 5. Minimum 80% compliance with daily eCOAs (electronic Clinical Outcome Assessments) during the 14 days preceding Visit 3. 6. For female of child bearing potential participants, a negative urine pregnancy test prior to administration of IMP. Exclusion Criteria: 1. A severe asthma exacerbation within 8 weeks prior to randomisation. 2. History of herpes zoster reactivation. 3. Participants with a significant COVID-19 illness within 6 months of enrolment. 4. Clinically important pulmonary disease other than asthma. 5. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could: * affect the safety of the participant throughout the study, * influence the findings of the study or the interpretation, or * impede the participant's ability to complete the entire duration of study. 6. Any clinically significant cardiac or cerebrovascular disease. 7. History of venous thromboembolism. 8. Participants who, as judged by the investigator, have evidence of active TB, or latent TB without completion of an appropriate course of treatment or appropriate ongoing prophylactic treatment. 9. Participants with a recent history of, or who have a positive test for, infective hepatitis or unexplained jaundice, or participants who have been treated for HIV. 10. Current or prior history of alcohol or drug abuse (including marijuana and marijuana containing valid prescriptions), as judged by the investigator. 11. History of malignancy other than superficial basal cell carcinoma. 12. Treatment with systemic corticosteroid within 4 weeks (oral) or 8 weeks (intramuscular) before Visit 1. 13. Any immunosuppressive therapy within 12 weeks prior to Visit 1. 14. Treatment with marketed biologics within 6 months of Visit 1 or 5 half-lives, whichever is longer. 15. Inhaled corticosteroid plus fast-acting β2 agonist as a reliever is not allowed 15 days prior to Visit 1, during Screening/Run-in and throughout the Treatment period and preferably 1 week after the last dose of IMP. 16. Live, attenuated, or mRNA vaccines within 4 weeks of Visit 1. 17. Immunoglobulin or blood products within 4 weeks of Visit 1. 18. Any immunotherapy within 6 months of Visit 1, except for stable maintenance dose allergen-specific immunotherapy started at least 4 weeks prior to Visit 1 and expected to continue through to the end of the Follow-up period. 19. Concurrent enrolment in another interventional clinical study 20. Participant treated with any investigational drug within 4 months or 5 half-lives, whichever is longer, prior to Visit 1. 21. Participants with a known hypersensitivity to AZD4604 or any of the excipients of the product. 22. Abnormal findings identified on physical examination, ECG, or laboratory testing. 23. For female participants only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding. 24. Current smokers or participants with smoking history ≥ 10 pack-years. 25. Participants with a known long-term exposure to occupational asbestos, silica, radon, heavy metals, and polycyclic aromatic hydrocarbons. 26. Positive family history of primary lung cancer in first degree relatives (mother, father, sisters, brothers and children). 27. Positive urine cotinine test or exhaled carbon monoxide test at Visit 1 and at any timepoint throughout the study. 28. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 29. Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements. 30. Donation of blood (≥ 450 mL) within 3 months or donation of plasma within 14 days before Visit 1. 31. Major surgery within 8 weeks prior to Visit 1, or planned inpatient surgery, major dental procedure or hospitalisation during Screening, Treatment, or Follow-up periods.

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

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

Asthma

Contacts and locations

Locations

Research Site

Birmingham, Alabama, 35209, United States
Research Site

Chandler, Arizona, 85224, United States
Research Site

Newport Beach, California, 92663, United States
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Sacramento, California, 95817, United States
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Lakeland, Florida, 33813, United States
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Miami, Florida, 33126, United States
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Atlanta, Georgia, 30344, United States
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Hammond, Indiana, 46324, United States
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New Bedford, Massachusetts, 02740, United States
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Ann Arbor, Michigan, 48109, United States
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Southfield, Michigan, 48075, United States
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Saint Charles, Missouri, 63301, United States
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Las Vegas, Nevada, 89106, United States
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Union City, New Jersey, 07087, United States
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Charlotte, North Carolina, 28207, United States
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New Bern, North Carolina, 28562, United States
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Salisbury, North Carolina, 28144, United States
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Winston-Salem, North Carolina, 27104, United States
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Columbus, Ohio, 43207, United States
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Boerne, Texas, 78006, United States
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El Paso, Texas, 79902, United States
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Houston, Texas, 77074, United States
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Buenos Aires, C1012AAR, Argentina
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Buenos Aires, C1425BEN, Argentina
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Ciudad de Buenos Aires, 1425, Argentina
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Ciudad de Buenos Aires, C1414AIF, Argentina
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Florida, B1602DQD, Argentina
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La Plata, B1900AVG, Argentina
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Ranelagh, 1886, Argentina
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Barretos, 14784-400, Brazil
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Blumenau, 89030-101, Brazil
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Campinas, 13060-080, Brazil
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Campinas, 13060-904, Brazil
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Porto Alegre, 90035074, Brazil
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Porto Alegre, 90160-093, Brazil
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São Bernardo do Campo, 09715090, Brazil
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São Bernardo do Campo, 09750-420, Brazil
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São José do Rio Preto, 15090-000, Brazil
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Pazardzhik, 4400, Bulgaria
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Aalborg, 9000, Denmark
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Aarhus, 8200, Denmark
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Hvidovre, 2650, Denmark
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København NV, 2400, Denmark
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København Ø, 2100, Denmark
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Vejle, 7100, Denmark
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Lyon, 69317, France
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Strasbourg, 67091, France
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Berlin, 10367, Germany
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Berlin, 12159, Germany
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Berlin, 12203, Germany
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Berlin, 13187, Germany
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Cottbus, 03050, Germany
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Frankfurt am Main, 60596, Germany
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Koblenz, 56068, Germany
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Mainz, 55128, Germany
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Peine, 31224, Germany
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Ajmer, 305001, India
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Belagavi, 590010, India
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Coimbatore, 641028, India
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Hyderabad, 500068, India
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Kolkata, 700014, India
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Kozhikode, 673008, India
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New Delhi, 110029, India
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Kajang, 43000, Malaysia
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Kota Bharu, 15586, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Kuantan, 25100, Malaysia
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Malacca, 75400, Malaysia
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Sarawak Miri, 98000, Malaysia
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Sungai Buloh, 47000, Malaysia
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Dagupan, 2400, Philippines
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Davao City, PH-8000, Philippines
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Mabalacat, 2023, Philippines
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Manadaluyong City, 1552, Philippines
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Quezon City, 0870, Philippines
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Roxas City, 5800, Philippines
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Cape Town, 7764, South Africa
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Durban, 4001, South Africa
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Durban, 4091, South Africa
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eMkhomazi, 4170, South Africa
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Newton, 2113, South Africa
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Observatory, 7925, South Africa
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Daegu, 42415, South Korea
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Gyeonggi-do, 13620, South Korea
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Incheon, 21565, South Korea
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Seoul, 03722, South Korea
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Seoul, 04763, South Korea
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Barcelona, 8035, Spain
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Madrid, 28041, Spain
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Majadahonda, 28222, Spain
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Palma de Mallorca, 07010, Spain
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Linköping, 587 58, Sweden
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Lund, 22185, Sweden
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Örebro, 70185, Sweden
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Kaohsiung City, 80756, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 100, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 110, Taiwan
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Taipei, 112, Taiwan
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Taipei, 11696, Taiwan
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Taoyuan City, 330, Taiwan
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Yunlin, 640, Taiwan
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Bangkok, 10400, Thailand
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Chiang Mai, 50200, Thailand
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Hat Yai, 90110, Thailand
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Khlong Luang, 12120, Thailand
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Khon Kaen, 40002, Thailand
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Birmingham, B9 5SS, United Kingdom
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Bradford, BD9 6RJ, United Kingdom
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Chesterfield, S40 4AA, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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Liverpool, L7 8YE, United Kingdom
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London, W6 7HY, United Kingdom
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Penzance, TR18 3DX, United Kingdom
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Thetford, IP24 1JD, United Kingdom
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Wellingborough, NN8 4RW, United Kingdom
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Da Nang, 55000, Vietnam
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Hanoi, 100000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Hochiminh, 70000, Vietnam
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Hồ Chí Minh, 700000, Vietnam
Research Site

Huế, 530000, Vietnam

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