A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD
Launched by ASTRAZENECA · Mar 12, 2025
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the effectiveness and safety of a medication called Tezepelumab for adults with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung condition that makes it hard to breathe. The study is currently recruiting participants aged between 40 and 80 years who have been diagnosed with COPD for at least a year, have had recent trouble with their breathing, and have been using certain inhaled medications for at least three months. Participants should also have had at least two moderate flare-ups or one severe flare-up of their COPD in the past year.
If you decide to join this trial, you will be randomly assigned to receive either Tezepelumab or a placebo (a treatment that looks like the medication but has no active ingredients) for a specific period. Throughout the study, your health will be closely monitored, and you’ll attend regular check-ups to see how you’re doing. It’s important to note that certain conditions, like having other serious lung diseases or current treatments that could interfere with the study, may prevent you from participating. This trial aims to find better ways to manage COPD and improve the quality of life for those affected by it.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. ≥40 to ≤80 years old
- • 2. COPD diagnosis ≥1 year,
- • 3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening
- • 4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy ≥3 consecutive months prior to V1
- • 5. ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids
- • 6. EOS ≥ 150 cells/μL during screening
- • 7. CAT ≥15 at screening
- • 8. Former or current smokers ≥10 pack-years
- Exclusion Criteria:
- • 1. Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD
- • 2. Asthma, incl. pediatric, or ACOS
- • 3. Any unstable disorder that can impact participants safety or study outcomes
- • 4. Tuberculosis requiring treatment within 12 months prior V2
- • 5. Malignancies current or past
- Concomitant therapies:
- • Macrolides (less than 6 months)
- • Systemic immuno-suppressive, -modulating medications
- • 6. LTOT \>4.0 L/min or O2 saturation \<89% despite LTOT
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tampa, Florida, United States
Sevilla, , Spain
Papillion, Nebraska, United States
Barcelona, , Spain
Napoli, , Italy
Sassari, , Italy
Málaga, , Spain
Cottingham, , United Kingdom
Buffalo, New York, United States
North Dartmouth, Massachusetts, United States
New Bern, North Carolina, United States
Winston Salem, North Carolina, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Scarborough, Ontario, Canada
Montreal, Quebec, Canada
Praha 1, , Czechia
Berlin, , Germany
Marburg, , Germany
Stuttgart, , Germany
Pavia, , Italy
Bradford, , United Kingdom
Leeds, , United Kingdom
Ajax, Ontario, Canada
Chihuahua, , Mexico
Johnson City, Tennessee, United States
Firenze, , Italy
Wilmington, North Carolina, United States
Wilmington, North Carolina, United States
San Juan Del Rio, , Mexico
Quezon City, , Philippines
Manila, , Philippines
Saskatoon, Saskatchewan, Canada
Valencia, , Spain
Glasgow, , United Kingdom
Brno, , Czechia
Madrid, , Spain
Franklin, Tennessee, United States
Buffalo, New York, United States
Teplice, , Czechia
Morelia, , Mexico
Martin, , Slovakia
Vancouver, British Columbia, Canada
Burlington, Ontario, Canada
Tucson, Arizona, United States
Beijing, , China
Rock Hill, South Carolina, United States
Roma, , Italy
Missoula, Montana, United States
Jindrichuv Hradec, , Czechia
Newport Beach, California, United States
Kerrville, Texas, United States
Mansfield, Texas, United States
Iloilo City, , Philippines
Torrance, California, United States
Portsmouth, , United Kingdom
Foley, Alabama, United States
Las Vegas, Nevada, United States
Saint Cloud, Minnesota, United States
Nanning, , China
Yinchuan, , China
Alor Setar, , Malaysia
Kuching, , Malaysia
Grodzisk Mazowiecki, , Poland
Chongqing, , China
Pamplona, , Spain
Milwaukee, Wisconsin, United States
Columbia, Maryland, United States
Mobile, Alabama, United States
Changchun, , China
Guangzhou, , China
Wuhan, , China
Guadalajara, , Mexico
Humenne, , Slovakia
Toms River, New Jersey, United States
Milan, , Italy
Miami, Florida, United States
Quebec, , Canada
Jinan, , China
Nanchang, , China
Seoul, , Korea, Republic Of
Veracruz, , Mexico
Chrzanów, , Poland
Sewell, New Jersey, United States
Changsha, , China
Nanjing, , China
Taiyuan, , China
Bydgoszcz, , Poland
Wakefield, , United Kingdom
Toronto, Ontario, Canada
Brandys Nad Labem, , Czechia
Iloilo, , Philippines
Plzen, , Czechia
Shenzhen, , China
Dublin, Ohio, United States
Yangzhou, , China
Daegu, , Korea, Republic Of
Debary, Florida, United States
Rincon, Georgia, United States
Farmington Hills, Michigan, United States
Windsor, Ontario, Canada
St Charles Borromee, Quebec, Canada
Sheffield, Alabama, United States
Pingxiang, , China
København Nv, , Denmark
Iksan Si, , Korea, Republic Of
Wonju Si, , Korea, Republic Of
Gainesville, Florida, United States
Granada, , Spain
Palma De Mallorca, , Spain
Winfield, Illinois, United States
Karczew, , Poland
Piaseczno, , Poland
Houston, Texas, United States
Tradate, , Italy
Quillota, , Chile
Haikou, , China
Shanghai, , China
Wenzhou, , China
Curico, , Chile
Białystok, , Poland
Katowice, , Poland
Lucknow, , India
Uijeongbu Si, , Korea, Republic Of
Barakaldo, , Spain
Hannover, , Germany
Lübeck, , Germany
Poznań, , Poland
Levice, , Slovakia
Anyang Si, , Korea, Republic Of
Kuantan, , Malaysia
Immenhausen, , Germany
Santiago, , Chile
Guangzhou, , China
Linhai, , China
Shijiazhuang, , China
Rosenheim, , Germany
Porto Alegre, , Brazil
Trois Rivières, Quebec, Canada
Gurgaon, , India
Madurai, , India
Cuernavaca, , Mexico
Homestead, Florida, United States
Lovosice, , Czechia
Varnsdorf, , Czechia
Xuzhou, , China
Cutler Bay, Florida, United States
Chengdu, , China
Hangzhou, , China
Campinas, , Brazil
Belagavi, , India
Shantou, , China
Changsha, , China
Yinchuan, , China
Lodz, , Poland
Cudahy, Wisconsin, United States
Dehradun, , India
Trnava, , Slovakia
Cortland, New York, United States
Wiesbaden, , Germany
Jinhua, , China
Yichang, , China
Fuzhou, , China
Nan Chong, , China
Ahmedabad, , India
Calgary, Alberta, Canada
Qingdao, , China
Sao Jose Do Rio Preto, , Brazil
Taizhou, , China
Coimbatore, , India
Las Pinas, , Philippines
Orlando, Florida, United States
Bragança Paulista, , Brazil
Brasilia, , Brazil
Evanston, Illinois, United States
Salvador, , Brazil
Oaxaca, , Mexico
Sanya, , China
Merida, , Mexico
Faridabad, , India
Pune, , India
Jeonju, , Korea, Republic Of
Ostróda, , Poland
Winchester, Ontario, Canada
Benito Juarez, , Mexico
Horseheads, New York, United States
Xinxiang, , China
Cuauhtémoc, , Mexico
Vadodara, , India
Delhi, , India
Shenyang, , China
Marilao, , Philippines
Kajang, , Malaysia
Tyne And Wear, , United Kingdom
Ostrava, , Czechia
Monterrey, , Mexico
Kuala Lumpur, , Malaysia
Brighton, , United Kingdom
Kuala Terengganu, , Malaysia
Kota Kinabalu, , Malaysia
Telese Terme, , Italy
Zhangzhou, , China
Zapopan, , Mexico
Tondo, , Philippines
Linhai, , China
Kolkata, , India
Hohhot, , China
Kochi, , India
Manadaluyong City, , Philippines
Talca, , Chile
Huizhou, , China
Tijuna, , Mexico
Kielce, , Poland
Płock, , Poland
Curitiba, , Brazil
Suining Shi, , China
Votuporanga, , Brazil
Chongqing, , China
Heze, , China
Nagpur, , India
Jaú, , Brazil
Lublin, , Poland
Praha 16, , Czechia
Nanning, , China
Hefei, , China
Tianjin, , China
High Point, North Carolina, United States
Chapeco, , Brazil
Mossoro, , Brazil
Vitoria, , Brazil
Bendorf, , Germany
Haltern Am See, , Germany
Mysuru, , India
Montebelluna, , Italy
Kraków, , Poland
Košice, , Slovakia
Halifax, , United Kingdom
Kings Mountain, North Carolina, United States
Anyang, , China
Hengyang City, , China
Qingyuan, , China
Concepción, , Chile
Loudi, , China
Saint Laurent, Quebec, Canada
Patients applied
Trial Officials
Dave Singh, MD
Principal Investigator
Division of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported