New shot aims to slash COPD attacks in former smokers

NCT ID NCT05166889

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

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

Summary

This study tested a new medicine called tozorakimab in over 1,100 adults with COPD who had frequent or severe flare-ups. Participants received either a low or high dose of the drug or a placebo as a shot under the skin, while continuing their usual inhalers. The main goal was to see if the drug could reduce the number of moderate to severe COPD attacks over time, 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

1,132 people

The number who actually took part.

Started

Jan 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

Huntsville, Alabama, 35801, United States
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Mobile, Alabama, 36608, United States
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Montgomery, Alabama, 36106, United States
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Phoenix, Arizona, 85044, United States
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Bakersfield, California, 93301, United States
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Sacramento, California, 95821, United States
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Boynton Beach, Florida, 33435, United States
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Ormond Beach, Florida, 32174, United States
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Plantation, Florida, 33324, United States
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Meridian, Idaho, 83642, United States
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Evergreen Park, Illinois, 60805, United States
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Normal, Illinois, 61761, United States
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Iowa City, Iowa, 52242, United States
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Kansas City, Kansas, 66104, United States
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Baton Rouge, Louisiana, 70816, United States
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Zachary, Louisiana, 70791, United States
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Baltimore, Maryland, 21224, United States
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Rochester, Minnesota, 55905, United States
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St Louis, Missouri, 63110, United States
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Missoula, Montana, 59808, United States
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Brick, New Jersey, 08724, United States
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New York, New York, 10037, United States
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The Bronx, New York, 10455, United States
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Charlotte, North Carolina, 28277, United States
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Durham, North Carolina, 27710, United States
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Gastonia, North Carolina, 28054, United States
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Fargo, North Dakota, 58104, United States
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DuBois, Pennsylvania, 15801, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Sayre, Pennsylvania, 18840, United States
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Rapid City, South Dakota, 57702, United States
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Franklin, Tennessee, 37067, United States
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Houston, Texas, 77022, United States
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Kingwood, Texas, 77339, United States
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Salt Lake City, Utah, 84108, United States
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Burlington, Vermont, 05401, United States
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Buenos Aires, C1121 ABE, Argentina
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CABA, C1425BEN, Argentina
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Ciudad de Buenos Aires, C1414AIF, Argentina
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Córdoba, X5003DCE, Argentina
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Mar del Plata, 7600, Argentina
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Mar del Plata, B7600GWV, Argentina
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Mendoza, M5500CCG, Argentina
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Quilmes, B1878FNR, Argentina
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San Fernando, B1646EBJ, Argentina
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San Juan Bautista, 1888, Argentina
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San Miguel de Tucumán, 4000, Argentina
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Brussels, 1000, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Namur, 5101, Belgium
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Dupnitsa, 2600, Bulgaria
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Haskovo, 6305, Bulgaria
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Kozloduy, 3320, Bulgaria
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Lovech, 5500, Bulgaria
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Petrich, 2850, Bulgaria
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Pleven, 5800, Bulgaria
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Rousse, 7002, Bulgaria
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Sliven, 8800, Bulgaria
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Sofia, 1000, Bulgaria
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Sofia, 1606, Bulgaria
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Troyan Municipality, 5600, Bulgaria
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Vratsa, 3000, Bulgaria
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Calgary, Alberta, T3E 7M8, Canada
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Edmonton, Alberta, T5A 4L8, Canada
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Sherwood Park, Alberta, T8L 0N2, Canada
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Kamloops, British Columbia, V2C 5T1, Canada
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Kelowna, British Columbia, V1Y 4N7, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Guelph, Ontario, N1H 6J2, Canada
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Markham, Ontario, L3T 0C8, Canada
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Stouffville, Ontario, L4A 1H2, Canada
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Winchester, Ontario, K0C 2K0, Canada
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Montreal, PQ, H3T 1E2, Canada
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Québec, Quebec, G1G 5X1, Canada
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Québec, Quebec, G1V 4G5, Canada
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Terrebonne, Quebec, J6V 2H2, Canada
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Brno, 625 00, Czechia
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Broumov, 55001, Czechia
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Jindřichův Hradec, 377 01, Czechia
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Liberec, 460 63, Czechia
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Olomouc, 779 00, Czechia
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Rokycany, 337 22, Czechia
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Aalborg, 9000, Denmark
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Hvidovre, 2650, Denmark
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København NV, 2400, Denmark
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Næstved, 4700, Denmark
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Roskilde, 4000, Denmark
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Vejle, 7100, Denmark
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Hämeenlinna, 13530, Finland
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Helsinki, 00290, Finland
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Kuopio, 70210, Finland
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Tampere, 33520, Finland
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Turku, 20100, Finland
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Turku, FI-20521, Finland
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Budapest, 1036, Hungary
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Debrecen, 4032, Hungary
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Edelény, 3780, Hungary
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Encs, 3860, Hungary
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Mosonmagyaróvár, 9200, Hungary
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Nyíregyháza-Sóstóhegy, 4481, Hungary
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Százhalombatta, 2440, Hungary
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Ahmedabad, 382415, India
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Belagavi, 590010, India
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Coimbatore, 641028, India
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Dehradun, 248001, India
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Hyderabad, 500038, India
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Jaipur, 302039, India
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Mohali, 160062, India
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Nagpur, 440012, India
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Nashik, 422007, India
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New Delhi, 110029, India
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Surat, 395009, India
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Thane, 401107, India
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Asahikawa-shi, 078-8510, Japan
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Chikushino-shi, 818-8502, Japan
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Chūōku, 103-0022, Japan
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Fujieda-shi, 426-8677, Japan
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Fukuoka, 819-8555, Japan
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Hamamatsu, 430-8525, Japan
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Hamamatsu, 431-3192, Japan
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Hiroshima, 734-8530, Japan
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Iizuka-shi, 820-8505, Japan
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Itabashi-ku, 173-8610, Japan
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Iwata-shi, 438-8550, Japan
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Joyo-shi, 610-0113, Japan
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Kagoshima, 890-8520, Japan
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Kanazawa, 920-8650, Japan
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Kawachinagano-shi, 586-8521, Japan
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Kitakyusyu-shi, 806-8501, Japan
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Kobe, 651-0072, Japan
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Koga-shi, 811-3195, Japan
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Kokubunji-shi, 185-0014, Japan
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Matsusaka-shi, 515-8544, Japan
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Mizunami-shi, 509-6134, Japan
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Nagaoka-shi, 940-8621, Japan
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Nagoya, 460-0001, Japan
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Obihiro, 080-0017, Japan
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Okayama, 700-8558, Japan
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Osaka, 531-0073, Japan
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Osaka, 543-8555, Japan
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Osaka, 545-8586, Japan
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Sakaishi, 590-0064, Japan
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Shinjuku-ku, 162-8655, Japan
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Shizuoka, 420-8630, Japan
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Toshima-ku, 170-0003, Japan
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Toyonaka-shi, 560-8552, Japan
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Yanagawa-shi, 832-0059, Japan
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Yokohama, 221-0855, Japan
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Yokohama, 223-0059, Japan
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Yokohama, 232-0024, Japan
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Benito Juárez, 03650, Mexico
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Chihuahua City, 31000, Mexico
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Guadalajara, 44100, Mexico
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Guadalajara, 44200, Mexico
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Mexico City, 0 3100, Mexico
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Mérida, 97070, Mexico
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Monterrey, 64460, Mexico
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Morelia, 58000, Mexico
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Oaxaca City, 68020, Mexico
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Veracruz, 91910, Mexico
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Alkmaar, 1815 JD, Netherlands
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Eindhoven, 5623EJ, Netherlands
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Groningen, 9713 GZ, Netherlands
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Harderwijk, 3844 DG, Netherlands
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Heerlen, 6419 PC, Netherlands
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Zutphen, 7207 AE, Netherlands
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Zwolle, 8025 AB, Netherlands
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Ålesund, 6017, Norway
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Bergen, 5021, Norway
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Bodø, 8092, Norway
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Levanger, 7600, Norway
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Lørenskog, 1478, Norway
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Oslo, 0450, Norway
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Tønsberg, 3103, Norway
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Guimarães, 4835-235, Portugal
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Lisbon, 1769-001, Portugal
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Lisbon, 1998-018, Portugal
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Matosinhos Municipality, 4454-509, Portugal
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Vila Franca de Xira, 2600-009, Portugal
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Vila Nova de Gaia, 4434-502, Portugal
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Guaynabo, 00968, Puerto Rico
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Daegu, 42415, South Korea
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Incheon, 21431, South Korea
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Jeonju, 54907, South Korea
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Seoul, 03722, South Korea
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Seoul, 05030, South Korea
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Seoul, 05505, South Korea
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Seoul, 06591, South Korea
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Seoul, 07061, South Korea
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Galdakao, 48960, Spain
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Madrid, 28040, Spain
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Málaga, 29010, Spain
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Mérida, 06800, Spain
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Pozuelo de Alarcón, 28223, Spain
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Santander, 39008, Spain
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Valencia, 46010, Spain
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Zaragoza, 50009, Spain
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Gothenburg, 413 45, Sweden
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Gothenburg, 413 46, Sweden
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Lund, 222 22, Sweden
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Malmö, 205 02, Sweden
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Stockholm, 11239, Sweden
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Ankara, 06620, Turkey (Türkiye)
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Aydin, 09100, Turkey (Türkiye)
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Istanbul, 34069, Turkey (Türkiye)
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Izmir, 35040, Turkey (Türkiye)
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Izmir, 35965, Turkey (Türkiye)
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Mersin, 33343, Turkey (Türkiye)
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Hanoi, 100000, Vietnam
Research Site

Ho Chi Minh City, 700000, Vietnam

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