Back to Trials
NCT07082738PHASE2Recruiting

A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

AstraZeneca

Start Date

6/27/2025

Completion Date

11/5/2027

Summary

This Phase IIb dose-ranging study will evaluate the efficacy and safety of 2 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.

Detailed Description

A Multicentre, Parallel-group, Phase IIb, Randomised, Double-blind, Placebo-controlled, 3-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO) Approximately 350 sites globally will participate in this study. Approximately 970 participants will be randomized to AZD6793 or Placebo. Following CSP V.3.0, participants will be randomized in a 1:1:1 ratio of two doses of AZD6793 vs Placebo.

Eligibility Criteria

Age Range: 40 years to No maximum

Inclusion Criteria: * Participant must be ≥40 years of age at the time of signing the informed consent. * Documented primary diagnosis of COPD for at least 12 months prior to enrolment. * Pre-BD FEV1/FVC \< 0.7 at Visit 1 and pre- and post-BD FEV1/FVC \< 0.7, and post-BD FEV1 ≥ 25% to \< 80% of predicted normal at Visit 2. * Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations in the 12 months prior to screening. * Documented stable regimen of inhaled triple maintenance therapy or inhaled dual maintenance therapy for ≥ 3 months prior to screening. * CAT score ≥ 10 at Visit 1. * Current or ex-smokers with a cigarette smoking history of ≥ 10 pack-years. * Participants who are clinically stable and free from an exacerbation of COPD for 4 weeks prior to Visit 1 and are also exacerbation free for at least 4 weeks (28 days) prior to Visit 3 (randomisation). * Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP). Exclusion Criteria: * Clinically important pulmonary disease other than COPD (eg, asthma \[current diagnosis per GINA or other accepted guidelines\], active pulmonary infection, clinically significant bronchiectasis when bronchiectasis is the predominant diagnosis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha-1 antitrypsin deficiency or primary ciliary dyskinesia). * Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms. * Any unstable disorder, including, but not limited to, CV, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment. * Significant left heart failure. * Unstable angina, acute coronary syndrome/acute myocardial infarction or coronary intervention with percutaneous coronary intervention/coronary artery bypass graft within 6 months of randomisation, uncontrolled arrhythmia, or cardiomyopathy, clinically significant aortic stenosis, or signs of pulmonary oedema or volume overload. * Pulmonary arterial hypertension, either idiopathic or due to connective tissue or thromboembolic disease. * History of another underlying condition that predisposes the participant to infections. * History of ulcerative colitis, Crohn's disease, or microscopic colitis diagnosed by either a gastroenterologist or by histopathology. * Abnormal laboratory findings. * Participants with evidence of active liver disease and/or evidence of chronic liver disease. * Participants with history of HIV infection or who test positive for HIV. * History of lung volume reduction surgery. * Current or history of malignancy within 5 years before the screening visit.

Interventions

DRUG

AZD6793

OTHER

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Locations

Research Site

Birmingham, Alabama 35205

United States

Research Site

Glendale, Arizona 85306

United States

Research Site

Phoenix, Arizona 85027

United States

Research Site

Phoenix, Arizona 85044

United States

Research Site

Phoenix, Arizona 85051

United States

Research Site

Canoga Park, California 91303

United States

Research Site

La Mesa, California 91942

United States

Research Site

Los Angeles, California 90017

United States

Research Site

Newport Beach, California 92663

United States

Research Site

Norco, California 92860

United States

Research Site

Tustin, California 92780

United States

Research Site

Lakewood, Colorado 80228

United States

Research Site

Brandon, Florida 33511

United States

Research Site

Cape Coral, Florida 33990

United States

Research Site

Clearwater, Florida 33756

United States

Research Site

Clearwater, Florida 33765

United States

Research Site

Jacksonville, Florida 32216

United States

Research Site

Lake City, Florida 32055

United States

Research Site

Miami, Florida 33125

United States

Research Site

Miami, Florida 33155

United States

Research Site

Miami, Florida 33173

United States

Research Site

Miami, Florida 33175

United States

Research Site

Miami, Florida 33182

United States

Research Site

Miami Lakes, Florida 33016

United States

Research Site

Naples, Florida 34102

United States

Research Site

Ocala, Florida 34471

United States

Research Site

Ormond Beach, Florida 32174

United States

Research Site

Plantation, Florida 33324

United States

Research Site

Sarasota, Florida 34239

United States

Research Site

Tamarac, Florida 33321

United States

Research Site

Tampa, Florida 33606

United States

Research Site

Tampa, Florida 33607

United States

Research Site

Winter Park, Florida 32789

United States

Research Site

Suwanee, Georgia 30024

United States

Research Site

West Des Moines, Iowa 50266

United States

Research Site

Lexington, Kentucky 40503

United States

Research Site

Zachary, Louisiana 70791

United States

Research Site

Baltimore, Maryland 21201

United States

Research Site

Baltimore, Maryland 21224

United States

Research Site

Burlington, Massachusetts 01805

United States

Research Site

Farmington Hills, Michigan 48336

United States

Research Site

Garden City, Michigan 48135

United States

Research Site

Grand Rapids, Michigan 49546

United States

Research Site

Chesterfield, Missouri 63005

United States

Research Site

Hannibal, Missouri 63401

United States

Research Site

St Louis, Missouri 63110

United States

Research Site

St Louis, Missouri 63141

United States

Research Site

Kalispell, Montana 59901

United States

Research Site

Mount Kisco, New York 10549

United States

Research Site

New Bern, North Carolina 28562

United States

Research Site

Cleveland, Ohio 44106

United States

Research Site

Marion, Ohio 43302

United States

Research Site

Oklahoma City, Oklahoma 73104

United States

Research Site

Tulsa, Oklahoma 74133

United States

Research Site

Medford, Oregon 97504

United States

Research Site

Portland, Oregon 97202

United States

Research Site

Camp Hill, Pennsylvania 17011

United States

Research Site

DuBois, Pennsylvania 15801

United States

Research Site

Philadelphia, Pennsylvania 19114

United States

Research Site

Philadelphia, Pennsylvania 19140

United States

Research Site

Pittsburgh, Pennsylvania 15213

United States

Research Site

Scottdale, Pennsylvania 15683

United States

Research Site

Smithfield, Pennsylvania 15478

United States

Research Site

Lancaster, South Carolina 29720

United States

Research Site

Spartanburg, South Carolina 29303

United States

Research Site

Rapid City, South Dakota 57702

United States

Research Site

Chattanooga, Tennessee 37421

United States

Research Site

Franklin, Tennessee 37067

United States

Research Site

Johnson City, Tennessee 37604

United States

Research Site

Boerne, Texas 78006

United States

Research Site

Dallas, Texas 75254

United States

Research Site

Denison, Texas 75020

United States

Research Site

El Paso, Texas 79902

United States

Research Site

Houston, Texas 77002

United States

Research Site

Houston, Texas 77008

United States

Research Site

Houston, Texas 77030

United States

Research Site

Kingwood, Texas 77339

United States

Research Site

Lewisville, Texas 75067

United States

Research Site

Mansfield, Texas 76063

United States

Research Site

McKinney, Texas 75069

United States

Research Site

Pearland, Texas 77584

United States

Research Site

Colchester, Vermont 05446

United States

Research Site

Norfolk, Virginia 23504

United States

Research Site

Williamsburg, Virginia 23188

United States

Research Site

Morgantown, West Virginia 26505

United States

Research Site

Madison, Wisconsin 53715

United States

Research Site

Alberdi, X5033DCE

Argentina

Research Site

CABA, C1426

Argentina

Research Site

Ciudad Autónoma de Bs As, C1182ACD

Argentina

Research Site

Ciudad de Buenos Aires, 1060

Argentina

Research Site

Ciudad de Buenos Aires, C1094AAD

Argentina

Research Site

Mar del Plata, 7600

Argentina

Research Site

Mar del Plata, B7600GWV

Argentina

Research Site

Mendoza, M5500CCG

Argentina

Research Site

Ranelagh, 1886

Argentina

Research Site

Rosario, 2000

Argentina

Research Site

San Miguel de Tucumán, 4000

Argentina

Research Site

Cairns, 4870

Australia

Research Site

Nedlands, 6009

Australia

Research Site

Norwood, 5067

Australia

Research Site

Osborne Park, 6017

Australia

Research Site

South Brisbane, 4101

Australia

Research Site

Wollongong, 2500

Australia

Research Site

Dupnitsa, 2600

Bulgaria

Research Site

Haskovo, 6300

Bulgaria

Research Site

Plovdiv, 4003

Bulgaria

Research Site

Sofia, 1756

Bulgaria

Research Site

Stara Zagora, 6003

Bulgaria

Research Site

Veliko Tarnovo, 5000

Bulgaria

Research Site

Yambol, 8600

Bulgaria

Research Site

Edmonton, Alberta T6G 2G3

Canada

Research Site

Winnipeg, Manitoba R3L 1Z5

Canada

Research Site

Truro, Nova Scotia B2N 1L2

Canada

Research Site

Ajax, Ontario L1S 2J5

Canada

Research Site

Burlington, Ontario L7N 3V2

Canada

Research Site

Guelph, Ontario N1H 6J2

Canada

Research Site

Hamilton, Ontario L8L 5G4

Canada

Research Site

Stoney Creek, Ontario L8G 2V6

Canada

Research Site

Québec, Quebec G1V 4G5

Canada

Research Site

Saint-Charles-Borromée, Quebec J6E 2B4

Canada

Research Site

Sherbrooke, Quebec J1H 5N4

Canada

Research Site

Trois-Rivières, Quebec G8T 7A1

Canada

Research Site

Trois-Rivières, Quebec G9A 4P3

Canada

Research Site

Victoriaville, Quebec G6P 3Z8

Canada

Research Site

Saskatoon, Saskatchewan S7N 0W8

Canada

Research Site

Chile, 7770484

Chile

Research Site

Concepción, 4070057

Chile

Research Site

Santiago, 7501126

Chile

Research Site

Santiago, 7750495

Chile

Research Site

Santiago, 8380453

Chile

Research Site

Talca, 3481349

Chile

Research Site

Temuco, 4810345

Chile

Research Site

Viña del Mar, 2540488

Chile

Research Site

Baotou, 014040

China

Research Site

Beijing, 100024

China

Research Site

Beijing, 100029

China

Research Site

Beijing, 101100

China

Research Site

Changchun, 130021

China

Research Site

Changsha, 410008

China

Research Site

Changsha, 410015

China

Research Site

Chengdu, 610021

China

Research Site

Chengdu, 610041

China

Research Site

Chengdu, 610072

China

Research Site

Chongqing, 400042

China

Research Site

Fuzhou, 350031

China

Research Site

Guangzhou, 510163

China

Research Site

Guangzhou, 510280

China

Research Site

Hangzhou, 310009

China

Research Site

Hohhot, 010050

China

Research Site

Jinan, 250013

China

Research Site

Kunming, 650032

China

Research Site

Linhai, 317000

China

Research Site

Nanchang, 330006

China

Research Site

Nanjing, 210006

China

Research Site

Nanning, 530021

China

Research Site

Qingdao, 266011

China

Research Site

Shanghai, 200025

China

Research Site

Shanghai, 200433

China

Research Site

Shenyang, 110004

China

Research Site

Wuhan, 430030

China

Research Site

Wuhan, 430060

China

Research Site

Xuzhou, 221000

China

Research Site

Zhengzhou, 450003

China

Research Site

Aalborg, 9000

Denmark

Research Site

Aarhus, 8200

Denmark

Research Site

Esbjerg, 6700

Denmark

Research Site

Hvidovre, 2650

Denmark

Research Site

Odense C, 5000

Denmark

Research Site

Roskilde, 4000

Denmark

Research Site

Ahrensburg, 22926

Germany

Research Site

Bendorf, 56170

Germany

Research Site

Berlin, 10119

Germany

Research Site

Berlin, 10787

Germany

Research Site

Berlin, 10961

Germany

Research Site

Berlin, 12157

Germany

Research Site

Berlin, 12159

Germany

Research Site

Berlin, 13187

Germany

Research Site

Darmstadt, 64283

Germany

Research Site

Halle, 06108

Germany

Research Site

Hanover, D-30173

Germany

Research Site

Landsberg, 86899

Germany

Research Site

Leipzig, 04347

Germany

Research Site

Lübeck, 23552

Germany

Research Site

Marburg, 35037

Germany

Research Site

Obertshausen, 63179

Germany

Research Site

Rosenheim, 83022

Germany

Research Site

Schleswig, 24837

Germany

Research Site

Wiesbaden, 65183

Germany

Research Site

Witten, 58452

Germany

Research Site

Athens, 11521

Greece

Research Site

Athens, 11527

Greece

Research Site

Athens, 17562

Greece

Research Site

Ioannina, 45500

Greece

Research Site

Thessaloniki, 57001

Greece

Research Site

Thessaloniki, 57010

Greece

Research Site

Balassagyarmat, 2660

Hungary

Research Site

Budapest, 1044

Hungary

Research Site

Debrecen, 4032

Hungary

Research Site

Edelény, 3780

Hungary

Research Site

Encs, 3860

Hungary

Research Site

Gödöllő, 2100

Hungary

Research Site

Hajdúnánás, 4080

Hungary

Research Site

Nyíregyháza-Sóstóhegy, 4481

Hungary

Research Site

Pécs, 7635

Hungary

Research Site

Szombathely, 9700

Hungary

Research Site

Törökbálint, 2045

Hungary

Research Site

Belagavi, 590010

India

Research Site

Coimbatore, 641028

India

Research Site

Dehradun, 248001

India

Research Site

Delhi, 110029

India

Research Site

Delhi, 110029

India

Research Site

Dwārka, 110075

India

Research Site

Hyderabad, 500055

India

Research Site

Hyderabad, 500068

India

Research Site

Kochi, 682018

India

Research Site

Mumbai, 400008

India

Research Site

Nagpur, 440019

India

Research Site

Vijayawada, 520 008

India

Research Site

Busto Arsizio, 21052

Italy

Research Site

Cuneo, 12100

Italy

Research Site

Ferrara, 44100

Italy

Research Site

Milan, 20122

Italy

Research Site

Monza, 20900

Italy

Research Site

Naples, 80131

Italy

Research Site

Pavia, 27100

Italy

Research Site

Roma, 00161

Italy

Research Site

Statte, 74010

Italy

Research Site

Telese Terme, 82037

Italy

Research Site

Chiba, 260-0852

Japan

Research Site

Fukuoka, 814-0180

Japan

Research Site

Fukushima, 960-1295

Japan

Research Site

Ginowan-shi, 901-2214

Japan

Research Site

Hachioji-shi, 193-0998

Japan

Research Site

Hamamatsu, 431-3192

Japan

Research Site

Hiroshima, 734-8530

Japan

Research Site

Izumi-shi, 594-0073

Japan

Research Site

Kamakura, 247-8533

Japan

Research Site

Kanazawa, 920-8650

Japan

Research Site

Kasuga-shi, 816-0813

Japan

Research Site

Kawasaki-shi, 216-8511

Japan

Research Site

Kiyosu-shi, 452-0001

Japan

Research Site

Kochi, 780-8077

Japan

Research Site

Kōtoku, 136-0075

Japan

Research Site

Kumamoto, 861-8520

Japan

Research Site

Kyoto, 612-8555

Japan

Research Site

Maebashi, 371-8511

Japan

Research Site

Matsuyama, 790-8524

Japan

Research Site

Minoh, 562-0003

Japan

Research Site

Minokamo Shi, 505-8510

Japan

Research Site

Miura, 238-0111

Japan

Research Site

Mizunami-shi, 509-6134

Japan

Research Site

Osaka, 545-8586

Japan

Research Site

Ōita, 870-0033

Japan

Research Site

Sagamihara-shi, 252-0143

Japan

Research Site

Sapporo, 063-0005

Japan

Research Site

Sasebo-shi, 857-8511

Japan

Research Site

Shimotsuga-gun, 321-0293

Japan

Research Site

Shinjuku-ku, 160-0023

Japan

Research Site

Tachikawa-shi, 190-8531

Japan

Research Site

Toon-shi, 791-0281

Japan

Research Site

Toyota, 471-0062

Japan

Research Site

Ube, 755-8505

Japan

Research Site

Yokkaichi-shi, 510-8561

Japan

Research Site

Yokohama, 227-8501

Japan

Research Site

Yokohama, 245-8575

Japan

Research Site

Chihuahua City, 31210

Mexico

Research Site

Durango, 34000

Mexico

Research Site

Guadalajara, 44100

Mexico

Research Site

Guadalajara, 44200

Mexico

Research Site

Mexico City, 04100

Mexico

Research Site

Mexico City, 14050

Mexico

Research Site

Monterrey, 64060

Mexico

Research Site

Monterrey, 64460

Mexico

Research Site

Monterrey, 64465

Mexico

Research Site

Monterrey, 64710

Mexico

Research Site

Lima, 15024

Peru

Research Site

Lima, 15036

Peru

Research Site

Lima, 15082

Peru

Research Site

Lima, 15088

Peru

Research Site

Lima, 15102

Peru

Research Site

Lima, 15324

Peru

Research Site

Lima, LIMA 1

Peru

Research Site

Lima, Lima 33

Peru

Research Site

Bialystok, 15-044

Poland

Research Site

Bydgoszcz, 85-796

Poland

Research Site

Chęciny, 26-060

Poland

Research Site

Elblag, 82-300

Poland

Research Site

Karczew, 05-480

Poland

Research Site

Katowice, 40-081

Poland

Research Site

Katowice, 40-648

Poland

Research Site

Komorniki, 62-052

Poland

Research Site

Ksawerów, 95-054

Poland

Research Site

Lodz, 92-213

Poland

Research Site

Ostróda, 14-100

Poland

Research Site

Piaseczno, 05-500

Poland

Research Site

Piaseczno, 05-500

Poland

Research Site

Poznan, 60-693

Poland

Research Site

Płock, 09-407

Poland

Research Site

Rzeszów, 35-205

Poland

Research Site

Sosnowiec, 41-208

Poland

Research Site

Szczecin, 71-434

Poland

Research Site

Warsaw, 00-719

Poland

Research Site

Anyang-si, 14068

South Korea

Research Site

Cheongju-si, 28644

South Korea

Research Site

Chuncheon, 200-704

South Korea

Research Site

Daegu, 42415

South Korea

Research Site

Daegu, 42601

South Korea

Research Site

Jeonju, 54907

South Korea

Research Site

Seongnam-si, 13520

South Korea

Research Site

Seoul, 03181

South Korea

Research Site

Seoul, 06591

South Korea

Research Site

Seoul, 07061

South Korea

Research Site

Seoul, 08308

South Korea

Research Site

Seoul, 143-729

South Korea

Research Site

Seoul, 150-713

South Korea

Research Site

Wŏnju, 26426

South Korea

Research Site

Benalmádena, 29631

Spain

Research Site

Granollers, 08402

Spain

Research Site

Madrid, 28007

Spain

Research Site

Málaga, 29010

Spain

Research Site

Mérida, 06800

Spain

Research Site

Pozuelo de Alarcón, 28223

Spain

Research Site

Santander, 39008

Spain

Research Site

Changhua, 500

Taiwan

Research Site

Kaohsiung City, 80756

Taiwan

Research Site

Kaohsiung City, 824

Taiwan

Research Site

Taichung, 40447

Taiwan

Research Site

Taichung, 40705

Taiwan

Research Site

Taichung, 433004

Taiwan

Research Site

Taipei, 10002

Taiwan

Research Site

Taipei, 11696

Taiwan

Research Site

Taoyuan, 333

Taiwan

Research Site

Yung Kang City, 71044

Taiwan

Research Site

Adana, 1330

Turkey (Türkiye)

Research Site

Ankara, 06530

Turkey (Türkiye)

Research Site

Bursa, 16059

Turkey (Türkiye)

Research Site

İzmit, 41380

Turkey (Türkiye)

Research Site

Kayseri, 38039

Turkey (Türkiye)

Research Site

Mersin, 33343

Turkey (Türkiye)

Research Site

Chernivtsi, 58029

Ukraine

Research Site

Ivano-Frankivsk, 76018

Ukraine

Research Site

Ivano-Frankivsk, 76019

Ukraine

Research Site

Kyiv, 02002

Ukraine

Research Site

Kyiv, 02081

Ukraine

Research Site

Kyiv, 02091

Ukraine

Research Site

Kyiv, 03037

Ukraine

Research Site

Kyiv, 03680

Ukraine

Research Site

Lutsk, 43000

Ukraine

Research Site

Ternopil, 46000

Ukraine

Research Site

Uzhhorod, 88018

Ukraine

Research Site

Bradford, BD9 6RJ

United Kingdom

Research Site

Cottingham, HU16 5JQ

United Kingdom

Research Site

Glasgow, G4 0SF

United Kingdom

Research Site

Harrow, HA1 3UJ

United Kingdom

Research Site

London, EC1M 6BQ

United Kingdom

Research Site

London, NW3 2QG

United Kingdom

Research Site

Newcastle upon Tyne, NE1 4LP

United Kingdom

Research Site

Thetford, IP24 1JD

United Kingdom

Research Site

Wythenshawe, M23 9QZ

United Kingdom

Research Site

Da Nang, 55000

Vietnam

Research Site

Dong Thập, 83000

Vietnam

Research Site

Hanoi, 100000

Vietnam

Research Site

Hanoi, 100000

Vietnam

Research Site

Hanoi, 10000

Vietnam

Research Site

Hà Nội, 100000

Vietnam

Research Site

Ho Chi Minh City, 700000

Vietnam

Research Site

Huế, 530000

Vietnam

Research Site

Rach Gia, 920000

Vietnam