New shot could cut COPD attacks in former smokers

NCT ID NCT05158387

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

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

Summary

This study tested two doses of a drug called tozorakimab in over 1,100 adults with COPD who had frequent flare-ups. Participants received either the drug or a placebo as a shot, while continuing their usual inhalers. The main goal was to see if the drug could reduce the number of moderate to severe COPD attacks, especially in former smokers.

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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

1,172 people

The number who actually took part.

Started

Feb 2022

Finished

Mar 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

40 to 130 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. Participant must be ≥ 40 years of age and capable of giving signed informed consent. 2. Documented diagnosis of COPD for at least one year prior to enrolment. 3. Post BD FEV1/FVC \< 0.70 and post-BD FEV1 \>20% of predicted normal value. 4. Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment. 5. Documented optimized inhaled dual or triple therapy at a stable dose for at least 3 months prior to enrolment. 6. Smoking history of ≥ 10 pack-years. 7. CAT total score ≥10, with each of the phlegm (sputum) and cough items with a score ≥ 2 Exclusion Criteria: 1. Clinically important pulmonary disease other than COPD. 2. Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms. 3. Current diagnosis of asthma, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved before the age of 18. 4. Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment that could affect safety, study findings or participants ability to complete the study. 5. COPD exacerbation, within 2 weeks prior to randomization, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization. 6. Active significant infection within the 4 weeks prior to randomization, pneumonia within 6 weeks prior to randomization, or medical condition that predisposes the participant to infection. 7. Suspicion of, or confirmed, ongoing SARS-CoV-2 infection. 8. Significant COVID-19 illness within the 6 months prior to enrolment. 9. Unstable cardiovascular disorder. 10. Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure. 11. History of known immunodeficiency disorder, including a positive test for HIV-1 or HIV 2. 12. History of positive test or treatment for hepatitis B or hepatitis C (except for cured hepatitis C) 13. Evidence of active liver disease, including jaundice during screening. 14. Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than one year prior to enrolment. Suspected malignancy or undefined neoplasms. 15. Participants who have evidence of active TB. 16. Participants that have previously received tozorakimab. 17. Any clinically significant abnormal findings in physical examination, vital signs, ECG, or laboratory testing during the screening period, which in the opinion of the investigator may put the participant at risk because of their participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study. 18. Active vaping of any products or using smoked marijuana within the 6 months prior to randomization and during the study.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

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

Chronic obstructive pulmonary disease (COPD)

Contacts and locations

Locations

Research Site

Sheffield, Alabama, 35660, United States
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Lincoln, California, 95648, United States
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Newport Beach, California, 92663, United States
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Northridge, California, 91324, United States
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Colorado Springs, Colorado, 80909, United States
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Newark, Delaware, 19713, United States
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Bay Pines, Florida, 33744, United States
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Cape Coral, Florida, 33990, United States
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Pensacola, Florida, 32503, United States
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Tampa, Florida, 33607, United States
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Winter Park, Florida, 32789, United States
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Macon, Georgia, 31201, United States
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Greenwood, Indiana, 46143, United States
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Bowling Green, Kentucky, 42101, United States
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White Marsh, Maryland, 21162, United States
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North Dartmouth, Massachusetts, 02747, United States
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Ann Arbor, Michigan, 48109, United States
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Farmington Hills, Michigan, 48336, United States
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Grand Rapids, Michigan, 49546, United States
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Buffalo, New York, 14203, United States
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The Bronx, New York, 10459, United States
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Toledo, Ohio, 43617, United States
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Oklahoma City, Oklahoma, 73104, United States
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Tulsa, Oklahoma, 74133, United States
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Philadelphia, Pennsylvania, 19140, United States
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Rock Hill, South Carolina, 29732, United States
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Amarillo, Texas, 79106, United States
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Boerne, Texas, 78006, United States
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Fort Worth, Texas, 76104, United States
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McKinney, Texas, 75069, United States
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Tomball, Texas, 77375, United States
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Webster, Texas, 77598, United States
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Williamsburg, Virginia, 23188, United States
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Cudahy, Wisconsin, 53110, United States
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Campbelltown, 2560, Australia
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Frankstown, 3199, Australia
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Macquarie University, 2109, Australia
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Melbourne, 3000, Australia
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Nedlands, 6009, Australia
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Southport, 4215, Australia
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Spearwood, 6163, Australia
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Wollongong, 2500, Australia
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Woodville South, 5011, Australia
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Blumenau, 89030-101, Brazil
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Botucatu, 18618-686, Brazil
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Brasília, 71681-603, Brazil
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Curitiba, 80440-220, Brazil
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Porto Alegre, 90035074, Brazil
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Porto Alegre, 9061-000, Brazil
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Porto Alegre, 91010-006, Brazil
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Rio de Janeiro, 22061-080, Brazil
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São Bernardo do Campo, 09750-420, Brazil
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São Paulo, 01323-903, Brazil
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São Paulo, 01409-001, Brazil
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São Paulo, 05403-000, Brazil
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Curicó, 3341643, Chile
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Santiago, 7500010, Chile
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Santiago, 7500657, Chile
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Santiago, 7500698, Chile
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Santiago, 8150000, Chile
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Santiago, 8241479, Chile
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Talca, 3465584, Chile
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Baotou, 014010, China
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Beijing, 100144, China
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Beijing, 101200, China
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Changchun, 130021, China
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Changde, 415000, China
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Changsha, 410015, China
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Chengdu, 610000, China
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Chengdu, 610031, China
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Chengdu, 610083, China
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Chongqing, 400013, China
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Chongqing, 400037, China
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Guangzhou, 510120, China
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Guangzhou, 510180, China
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Guangzhou, 510630, China
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Haikou, 570311, China
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Hangzhou, 310006, China
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Hefei, 230001, China
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Hohhot, 010010, China
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Kunming, 650032, China
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Linhai, 317000, China
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Nanchang, 330006, China
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Nanjing, 210006, China
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Ningbo, 315010, China
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Shanghai, 200002, China
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Shanghai, 200433, China
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Shanghai, 201199, China
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Shengyang, 110004, China
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Shenyang, 110016, China
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Shenzhen, 518020, China
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Shenzhen, 518053, China
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Shijiazhuang, 50051, China
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Suzhou, 215002, China
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Taiyuan, 030001, China
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Tianjin, 300050, China
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Wuhan, 430022, China
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Wuxi, 214023, China
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Xiamen, 361004, China
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Xuzhou, 221000, China
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Xuzhou, 221009, China
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Yangzhou, 225001, China
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Yinchuan, 750004, China
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Zhanjiang, 524004, China
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Zunyi, 563100, China
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Barranquilla, 80007, Colombia
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Ibague, 730006, Colombia
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Rionegro, 054047, Colombia
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Zipaquirá, 200251, Colombia
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Brest, 29609, France
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Dijon, 21079, France
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Grenoble, 38043, France
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Lyon, 69317, France
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Marseille, 13915, France
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Montivilliers, 76290, France
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Montpellier, 34090, France
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Pessac, 33604, France
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Saint-Herblain, 44093, France
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Toulouse, 31059, France
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Ahrensburg, 22926, Germany
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Bamberg, 96049, Germany
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Berlin, 10717, Germany
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Berlin, 12157, Germany
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Cologne, 51069, Germany
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Darmstadt, 64283, Germany
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Halle, 6108, Germany
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Marburg, 35037, Germany
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München, 80336, Germany
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München-Pasing, 81241, Germany
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Peine, 31224, Germany
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Alexandroupoli, 68100, Greece
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Athens, 11527, Greece
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Exohi Thessaloniki, 57010, Greece
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Ioannina, 45500, Greece
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Pátrai, 26500, Greece
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Thessaloniki, 57010, Greece
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Ashkelon, 78278, Israel
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Beersheba, 8410101, Israel
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Jerusalem, 9372212, Israel
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Kfar Saba, 4428164, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 6423906, Israel
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Bari, 70124, Italy
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Massa, 54100, Italy
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Milan, 20142, Italy
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Milan, 20157, Italy
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Naples, 80131, Italy
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Roma, 00168, Italy
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Salerno, 84131, Italy
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San Donà di Piave, 30027, Italy
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Sassari, 07100, Italy
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Statte, 74010, Italy
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Telese Terme, 82037, Italy
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Tradate, 21049, Italy
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Vercelli, 13100, Italy
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Verona, 37134, Italy
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Lima, 15036, Peru
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Lima, 15046, Peru
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Lima, 15088, Peru
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Lima, LIMA 21, Peru
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Baguio City, 2600, Philippines
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Cebu City, 6000, Philippines
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Iloilo City, 5000, Philippines
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Bialystok, 15-044, Poland
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Bialystok, 15-704, Poland
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Bychawa, 23100, Poland
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Bydgoszcz, 85-796, Poland
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Katowice, 40-648, Poland
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Krakow, 30-033, Poland
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Lublin, 20-412, Poland
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Ostrowiec Świętokrzyski, 27-400, Poland
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Ostróda, 14-100, Poland
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Poznan, 60-693, Poland
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Poznan, 61-578, Poland
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Rzeszów, 35-205, Poland
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Skierniewice, 96-100, Poland
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Sosnowiec, 41-208, Poland
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Wroclaw, 53-301, Poland
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Ponce, 00717, Puerto Rico
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Brasov, 500283, Romania
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Bucharest, 050159, Romania
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Cluj-Napoca, 400371, Romania
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Constanța, 900002, Romania
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Timișoara, 300002, Romania
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Penza, 440067, Russia
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Saratov, 410012, Russia
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Hsinchu, 300, Taiwan
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Kaohsiung City, 807, Taiwan
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Kaohsiung City, 82445, Taiwan
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Taichung, 40443, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 100, Taiwan
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Taipei, 110, Taiwan
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Taoyuan, 333, Taiwan
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Yunlin, 640, Taiwan
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Bang Kra So, 11000, Thailand
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Bangkok, 10700, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Muang,, 55000, Thailand
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Muang, 22000, Thailand
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Mueang, 20000, Thailand
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Nakhon Ratchasima, 30000, Thailand
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Bradford, BD9 6RJ, United Kingdom
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Corby, NN17 2UR, United Kingdom
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Corby, NN18 9EZ, United Kingdom
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Enfield, EN3 4GS, United Kingdom
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Hampshire, SO16 6YD, United Kingdom
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High Wycombe, HP11 2QW, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Preston, PR2 9QB, United Kingdom
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Shipley, BD18 3SA, United Kingdom

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