New asthma pill shows promise in early trial

NCT ID NCT05251259

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

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

Summary

This study tested a daily pill called atuliflapon in 670 adults with moderate to severe asthma that is not well controlled by current treatments. The goal was to see if the drug could reduce asthma flare-ups over 12 weeks compared to a placebo. The trial is now complete, and results will help determine if further development is warranted.

What this could mean

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

Active substance: atuliflapon (also known as AZD5718)
What this could lead to: If successful, this could point toward a new daily pill to help control moderate to severe asthma and reduce flare-ups.
What could go wrong: This is an early Phase 2a study, so results may not confirm effectiveness. The drug may not work better than placebo, and side effects are still being evaluated.

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

670 people

The number who actually took part.

Started

Jan 2022

Finished

Jan 2026

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 Lead-in PK Cohort: * 18 to 55 years of age inclusive at the time of signing the informed consent at screening Visit 1. * Bodyweight 50 to 120 kg (inclusive) and BMI 18 to 32 kg/m\^2 (inclusive) at screening Visit 1. * Documented asthma diagnosis ≥12 months prior to screening Visit 1. * Able to perform acceptable lung function testing for FEV1 according to American Thoracic Society / European Respiratory Society (ATS/ERS) 2019 acceptability criteria. * Morning pre- bronchodilator (BD) forced expiratory volume (FEV)1 ≥ 40% predicted at screening Visit 1 and Visit 2. * Treated with low dose inhaled corticosteroid plus long-acting β2-agonist (ICS-LABA) or medium-high dose ICS alone or in combination with LABA at a stable dose for at least 3 months prior to screening Visit 1. Also, treatment with additional asthma controller therapies (eg, LAMA) at a stable dose ≥ 3 months prior to screening Visit 1 is allowed. * Participant's influenza/pneumonia vaccination is up to date as per local guidelines prior to Visit 2. General Inclusion Criteria for Part 1: * Body weight ≥ 40 kg and body mass index (BMI) \< 35 kg/m\^2. * Documented history of ≥ 1 severe asthma exacerbation within 1 year prior to screening Visit 1. * Able to perform acceptable lung function testing for FEV1 according to ATS/ERS 2019 acceptability criteria. * Morning pre-BD FEV1 between ≥ 40% and ≤ 85% predicted at screening Visit 1 and Visit 3. * An Asthma Control Questionnaire (ACQ)-6 score ≥ 1.5 at screening Visit 1 and at Visit 3. Exclusion Criteria * A severe asthma exacerbation within 8 weeks of screening (visit 1) or within 12 weeks of randomisation (Visit 3). * A positive test result of an approved antigen test (confirmed by a positive RT-PCR test) or a positive RT-PCR test for SARS-CoV-2, the virus responsible for COVID-19, at screening Visit 1 or at Visit 2 for the PK Lead-in cohort. For Part 1 the testing will be done at Visit 3. Results from the mandatory tests at Visit 2 (PK Lead-in cohort) and Visit 3 (Part 1) must not be older than 48 hours and must be available before randomisation. * Participants with a significant COVID-19 illness within 6 months of enrolment. * Clinically important pulmonary disease other than asthma. * 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. * Any clinically significant cardiac disease. * History of severe renal disease or history of creatinine clearance \< 30 mL/min × m2 calculated using Cockcroft-Gault equation. * Severe hepatic impairment (Child-Pugh class C). * Previous hepatotoxicity related to zileuton or leukotriene receptor antagonist (LTRAs) (eg montelukast). * 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 hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). * Evidence of active tuberculosis (TB), either treated or untreated or latent TB. * Current or history of alcohol or drug abuse (including marijuana). * Current diagnosis of cancer, not including in-situ or non-melanoma skin cancer or other previous malignancies where curative therapy was completed at least 5 years prior to screening Visit 1. * Clinically important ongoing or previous psychiatric disease, especially suicidal behaviour, that in the opinion of the investigator might compromise the safety of the participant in the study. * Treatment with any serum creatinine-altering drugs within 1 month prior to screening Visit 1 including but not limited to amphotericin, cimetidine, clofibrate, dronedarone, ketoconazole, probenecid, ranolazine, trimethoprim, aminoglycosides, or cephalosporins. * Treatment with systemic corticosteroid use within 8 weeks (oral) or 12 weeks (intramuscular) before screening (Visit 1) or 12 weeks (oral) or 16 weeks (IM) before randomization (Visit 3). * Treatment with marketed biologics including benralizumab, mepolizumab, reslizumab, omalizumab, and dupilumab within 6 months of screening Visit 1 or 5 half-lives whichever is longer. * Treatment with 5-lipoxygenase inhibitors (eg zileuton or other 5-LO inhibiting supplements) within 6 weeks prior to Visit 0 and within 8 weeks prior to Visit 1).Treatment with LTRAs (eg, montelukast) within 2 weeks prior to Visit 0 and within 4 weeks prior to screening Visit 1. * Inhaled corticosteroid + fast-acting β2 agonist as a reliever (eg Symbicort or Fostair Maintenance and Reliever Treatment) is not allowed 15 days prior to screening Visit 1, during screening (Visit 1)/run-in and the treatment period and preferably 1 week after the last dose of study intervention. * Live or attenuated vaccines within 4 weeks of screening Visit 1. * Immunoglobulin or blood products within 4 weeks of screening Visit 1. * Treatment with Gemfibrozil within 4 weeks of screening Visit 1. * Any immunotherapy within 6 months of screening Visit 1, except for stable maintenance dose allergen-specific immunotherapy started at least 4 weeks prior to screening Visit 1 and expected to continue through to the end of the follow-up period. * Potent inducers/inhibitors of cytochrome P450 3A4 within 4 weeks of screening Visit 1. * Treatment with simvastatin, lovastatin, and atorvastatin at doses \> 40 mg per day within 1 month prior to screening Visit 1. Treatment with sensitive cytochrome 3A substrates with narrow therapeutic window should be avoided from randomization to study drug. * For female participants on ethinyl oestradiol containing combined oral contraceptives, the ethinyl oestradiol doses exceeding 20 mcg per day. * Concurrent enrolment in another clinical study. * Previous participation in the current clinical study. * Participant treated with any investigational drug within 4 months prior to screening Visit 1. * Known history of allergy or reaction to any component of the study intervention formulation. * Smokers with smoking history of \< 10 pack-years or users of vaping or e-cigarettes, must have stopped at least 6 months prior to screening Visit 1. * Involvement in the planning and/or conduct of the study. * Donation of blood (≥ 450 mL) within 3 months or donation of plasma within 14 days before screening Visit 1. * Major surgery within 8 weeks prior to screening Visit 1, or planned inpatient surgery, major dental procedure or hospitalisation during the screening (Visit 1), 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, 35211, United States
Research Site

Sheffield, Alabama, 35660, United States
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Phoenix, Arizona, 85020, United States
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Tucson, Arizona, 85741, United States
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Little Rock, Arkansas, 72212, United States
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Bakersfield, California, 93301, United States
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Fountain Valley, California, 92708, United States
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Huntington Beach, California, 92647, United States
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Los Angeles, California, 90025, United States
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Newport Beach, California, 92663, United States
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San Jose, California, 95117, United States
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Valencia, California, 91355, United States
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Colorado Springs, Colorado, 80907, United States
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Cutler Bay, Florida, 33157, United States
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Cutler Bay, Florida, 33189, United States
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Hialeah, Florida, 33012, United States
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Hialeah, Florida, 33015, United States
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Hialeah, Florida, 33016, United States
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Miami, Florida, 33125, United States
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Miami, Florida, 33155, United States
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Miami, Florida, 33173, United States
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Miami, Florida, 33174, United States
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Orlando, Florida, 32807, United States
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Tampa, Florida, 33613, United States
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Tampa, Florida, 33615, United States
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Fayetteville, Georgia, 30214, United States
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Lithonia, Georgia, 30038, United States
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Savannah, Georgia, 31406, United States
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Boise, Idaho, 83706, United States
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Lexington, Kentucky, 40509, United States
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Owensboro, Kentucky, 42301, United States
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Oxon Hill, Maryland, 20745, United States
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New Bedford, Massachusetts, 02740, United States
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Ann Arbor, Michigan, 48105, United States
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Farmington Hills, Michigan, 48336, United States
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Saint Charles, Missouri, 63301, United States
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St Louis, Missouri, 63141, United States
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East Orange, New Jersey, 07018, United States
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Toms River, New Jersey, 08755, United States
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The Bronx, New York, 10459, United States
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Valhalla, New York, 10595, United States
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Charlotte, North Carolina, 28210, United States
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Charlotte, North Carolina, 28287, United States
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Gastonia, North Carolina, 28054, United States
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Wilmington, North Carolina, 28401, United States
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Blue Ash, Ohio, 45242, United States
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Dayton, Ohio, 45439, United States
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Edmond, Oklahoma, 73034, United States
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Pittsburgh, Pennsylvania, 15241, United States
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Columbia, South Carolina, 29204, United States
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Greenville, South Carolina, 29615, United States
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Spartanburg, South Carolina, 29303, United States
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Austin, Texas, 78705, United States
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Beaumont, Texas, 77701, United States
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Bellaire, Texas, 77401, United States
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Dallas, Texas, 75225, United States
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El Paso, Texas, 79902, United States
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El Paso, Texas, 79903, United States
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Houston, Texas, 77022, United States
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McKinney, Texas, 75069, United States
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San Antonio, Texas, 78258, United States
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Sugar Land, Texas, 77479, United States
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Tomball, Texas, 77375, United States
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Milwaukee, Wisconsin, 53228, United States
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Bahía Blanca, 8000, Argentina
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Buenos Aires, C1121ABE, Argentina
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Buenos Aires, C1414AIF, Argentina
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CABA, 1008, Argentina
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Capital Federal, C1122AAK, Argentina
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Ciudad Capital, 5500, Argentina
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Ciudad de Buenos Aire, C1425BEN, Argentina
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Concepción del Uruguay, 3260, Argentina
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Córdoba, X5003DCE, Argentina
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Florida, B1602DQD, Argentina
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Godoy Cruz, M5501ARP, Argentina
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La Plata, B1900, Argentina
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La Plata, B1902COS, Argentina
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Lobos, 7240, Argentina
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Mar del Plata, 7600, Argentina
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Mar del Plata, B7600, Argentina
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Mendoza, 5500, Argentina
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Mendoza, 5501, Argentina
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Mendoza, M5500CCG, Argentina
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Pilar, B1629AHJ, Argentina
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Quilmes, B1878FNR, Argentina
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Ramos Mejía, B1704ETD, Argentina
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Rosario, 2000, Argentina
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San Juan Bautista, 1888, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Santa Fe, 3000, Argentina
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Adelaide, 5000, Australia
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Clayton, 3168, Australia
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Kozloduy, 3320, Bulgaria
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Montana, 3400, Bulgaria
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Plovdiv, 4000, Bulgaria
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Rousse, 7000, Bulgaria
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Sliven, 8800, Bulgaria
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Sofia, 1113, Bulgaria
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Sofia, 1202, Bulgaria
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Sofia, 1407, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Velingrad, 4691, Bulgaria
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Vidin, 3700, Bulgaria
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Quillota, 2260000, Chile
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Santiago, 7500698, Chile
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Santiago, 7530234, Chile
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Santiago, 8330336, Chile
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Talca, 3481349, Chile
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Temuco, 4802815, Chile
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Viña del Mar, 2531172, Chile
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Vitacura, 7630226, Chile
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Klenovnik, 42244, Croatia
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Petrinja, 44250, Croatia
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Rijeka, 51000, Croatia
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Split, 21000, Croatia
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Zagreb, 10 000, Croatia
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Berlin, 12159, Germany
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Frankfurt, 60313, Germany
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Leipzig, 04103, Germany
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Lübeck, 23552, Germany
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Marburg, 35037, Germany
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Gödöllő, 2100, Hungary
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Gyula, 5700, Hungary
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Hajdúnánás, 4080, Hungary
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Pécs, 7635, Hungary
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Szombathely, 9700, Hungary
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Bunkyō City, 113-8510, Japan
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Chūōku, 103-0022, Japan
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Chūōku, 104-0031, Japan
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Fukuoka, 811-1351, Japan
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Fukuoka, 815-8588, Japan
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Fukuoka, 819-8555, Japan
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Himeji, 672-8064, Japan
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Kawachinagano-shi, 586-8521, Japan
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Kobe, 653-0013, Japan
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Kodaira-shi, 187-0024, Japan
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Koga-shi, 811-3195, Japan
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Kokubunji-shi, 185-0014, Japan
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Kyoto, 601-8213, Japan
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Nakagun, 259-0114, Japan
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Niigata, 940-0840, Japan
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Osaka, 530-0001, Japan
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Osaka, 531-0073, Japan
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Sagamihara-shi, 252-0315, Japan
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Sapporo, 064-0801, Japan
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Setagaya-ku, 157-0072, Japan
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Shibuya-Ku, 150-0013, Japan
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Tokyo, 157-0066, Japan
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Tokyo, 160-0017, Japan
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Toshima-ku, 170-0002, Japan
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Toshima-ku, 170-0003, Japan
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Yokohama, 223-0059, Japan
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Yokohama, 231-8682, Japan
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Breda, 4818 CK, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Groningen, 9713 GZ, Netherlands
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Bialystok, 15-044, Poland
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Gdansk, 80-382, Poland
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Grudziądz, 86-300, Poland
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Katowice, 40-282, Poland
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Katowice, 40-611, Poland
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Kielce, 25-751, Poland
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Krakow, 31-455, Poland
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Krakow, 31-513, Poland
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Ksawerów, 95-054, Poland
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Lodz, 90-127, Poland
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Lodz, 90-153, Poland
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Lodz, 90-302, Poland
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Ostróda, 14-100, Poland
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Poznan, 60-702, Poland
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Tarnów, 33-100, Poland
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Wroclaw, 50-381, Poland
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Wroclaw, 53-301, Poland
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Brasov, 500091, Romania
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Brasov, 500112, Romania
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Brasov, 500283, Romania
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Bucharest, 010626, Romania
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Bucharest, 014461, Romania
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Bucharest, 020125, Romania
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Bucharest, 061696, Romania
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Caracal, 235200, Romania
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Cluj-Napoca, 400371, Romania
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Deva, 330084, Romania
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Iași, 700115, Romania
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Resca, Com. Dobrosloveni, 237143, Romania
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Timișoara, 300310, Romania
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Belgrade, 11000, Serbia
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Belgrade, 11070, Serbia
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Užice, 31000, Serbia
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Valjevo, 14000, Serbia
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Levice, 934 01, Slovakia
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Prešov, 08001, Slovakia
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Topoľčany, 95501, Slovakia
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Germiston, 1401, South Africa
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Krugersdorp, 1740, South Africa
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Lenasia, 1827, South Africa
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Incheon, 405-760, South Korea
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Jeonju, 54907, South Korea
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Seoul, 02841, South Korea
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Seoul, 06591, South Korea
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Seoul, 138-736, South Korea
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Suwon, 16499, South Korea
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Badalona, 08916, Spain
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Barcelona, 08017, Spain
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Benalmádena, 29631, Spain
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Jerez de la Frontera, 11407, Spain
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Laredo, 39770, Spain
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Madrid, 28007, Spain
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Madrid, 28031, Spain
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Málaga, 29010, Spain
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Istanbul, 34093, Turkey (Türkiye)
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Chernivtsі, 58002, Ukraine
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Ivano-Frankivsk, 76000, Ukraine
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Kyiv, 01135, Ukraine
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Vinnytsia, 21029, Ukraine
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Birmingham, B15 2SQ, United Kingdom
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Bradford, BD9 6RJ, United Kingdom
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Cardiff, CF15 9SS, United Kingdom
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Chorley, PR7 7NA, United Kingdom
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Corby, NN17 2UR, United Kingdom
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Cottingham, HU16 5JQ, United Kingdom
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Glasgow, ML4 3NJ, United Kingdom
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Harefield, UB9 6JH, United Kingdom
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Hexham, NE46 1QJ, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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Leicester, LE3 9QP, United Kingdom
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Liverpool, L22 0LG, United Kingdom
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Liverpool, L7 8XP, United Kingdom
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London, SW10 9NH, United Kingdom
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London, W1T 6AH, United Kingdom
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London, W2 1NY, United Kingdom
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Manchester, M15 6SE, United Kingdom
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Portsmouth, PO6 3LY, United Kingdom
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Reading, RG1 5AN, United Kingdom

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