Chronic Obstructive Pulmonary Disease (COPD)Phase 2PRESTONCT07082738
A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
A Phase 2 study testing AZD6793 in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 367 sites in 24 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- AZD6793
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 987 participants
- Where
- 367 sitesin 24 countries
- Study dates
- 27 Jun 2025to 31 Aug 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
367 sites in 24 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
367 sites in 24 countries
United States86 sites, 70 recruiting
- Recruiting
Research Site
Baltimore, Maryland, 21201
- Recruiting
Research Site
Baltimore, Maryland, 21224
- Recruiting
Research Site
Birmingham, Alabama, 35205
- Recruiting
Research Site
Boerne, Texas, 78006
- Recruiting
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Brandon, Florida, 33511
- Recruiting
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Burlington, Massachusetts, 01805
- Recruiting
Research Site
Camp Hill, Pennsylvania, 17011
- Withdrawn
Research Site
Canoga Park, California, 91303
- Recruiting
Research Site
Cape Coral, Florida, 33990
- Recruiting
Research Site
Chattanooga, Tennessee, 37421
- Recruiting
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Chesterfield, Missouri, 63005
- Recruiting
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Clearwater, Florida, 33756
- Recruiting
Research Site
Clearwater, Florida, 33765
- Recruiting
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Cleveland, Ohio, 44106
- Recruiting
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Colchester, Vermont, 05446
- Recruiting
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Dallas, Texas, 75254
- Recruiting
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Denison, Texas, 75020
- Recruiting
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DuBois, Pennsylvania, 15801
- Recruiting
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El Paso, Texas, 79902
- Recruiting
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Farmington Hills, Michigan, 48336
- Recruiting
Research Site
Franklin, Tennessee, 37067
- Recruiting
Research Site
Garden City, Michigan, 48135
- Withdrawn
Research Site
Glendale, Arizona, 85306
- Recruiting
Research Site
Grand Rapids, Michigan, 49546
- Recruiting
Research Site
Hannibal, Missouri, 63401
- Withdrawn
Research Site
Houston, Texas, 77002
- Recruiting
Research Site
Houston, Texas, 77008
- Terminated
Research Site
Houston, Texas, 77030
- Withdrawn
Research Site
Jacksonville, Florida, 32216
- Withdrawn
Research Site
Johnson City, Tennessee, 37604
- Terminated
Research Site
Kingwood, Texas, 77339
- Withdrawn
Research Site
La Mesa, California, 91942
- Recruiting
Research Site
Lake City, Florida, 32055
- Withdrawn
Research Site
Lakewood, Colorado, 80228
- Recruiting
Research Site
Lancaster, South Carolina, 29720
- Recruiting
Research Site
Lewisville, Texas, 75067
- Terminated
Research Site
Lexington, Kentucky, 40503
- Recruiting
Research Site
Los Angeles, California, 90017
- Withdrawn
Research Site
Madison, Wisconsin, 53715
- Recruiting
Research Site
Mansfield, Texas, 76063
- Recruiting
Research Site
Marion, Ohio, 43302
- Recruiting
Research Site
McKinney, Texas, 75069
- Recruiting
Research Site
Medford, Oregon, 97504
- Recruiting
Research Site
Miami, Florida, 33125
- Recruiting
Research Site
Miami, Florida, 33155
- Recruiting
Research Site
Miami, Florida, 33173
- Recruiting
Research Site
Miami, Florida, 33175
- Recruiting
Research Site
Miami, Florida, 33182
- Recruiting
Research Site
Miami Lakes, Florida, 33016
- Recruiting
Research Site
Missoula, Montana, 59808
- Recruiting
Research Site
Morgantown, West Virginia, 26505
- Recruiting
Research Site
Mount Kisco, New York, 10549
- Recruiting
Research Site
Naples, Florida, 34102
- Recruiting
Research Site
New Bern, North Carolina, 28562
- Recruiting
Research Site
Newport Beach, California, 92663
- Recruiting
Research Site
Norco, California, 92860
- Recruiting
Research Site
Norfolk, Virginia, 23504
- Recruiting
Research Site
Ocala, Florida, 34471
- Recruiting
Research Site
Oklahoma City, Oklahoma, 73104
- Recruiting
Research Site
Ormond Beach, Florida, 32174
- Suspended
Research Site
Pearland, Texas, 77584
- Recruiting
Research Site
Philadelphia, Pennsylvania, 19114
- Recruiting
Research Site
Philadelphia, Pennsylvania, 19140
- Recruiting
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Phoenix, Arizona, 85027
- Recruiting
Research Site
Phoenix, Arizona, 85044
- Recruiting
Research Site
Phoenix, Arizona, 85051
- Recruiting
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Pittsburgh, Pennsylvania, 15213
- Recruiting
Research Site
Plantation, Florida, 33324
- Recruiting
Research Site
Portland, Oregon, 97202
- Recruiting
Research Site
Rapid City, South Dakota, 57702
- Recruiting
Research Site
Sarasota, Florida, 34239
- Terminated
Research Site
Scottdale, Pennsylvania, 15683
- Recruiting
Research Site
Smithfield, Pennsylvania, 15478
- Recruiting
Research Site
Spartanburg, South Carolina, 29303
- Recruiting
Research Site
St Louis, Missouri, 63110
- Recruiting
Research Site
St Louis, Missouri, 63141
- Withdrawn
Research Site
Suwanee, Georgia, 30024
- Recruiting
Research Site
Tamarac, Florida, 33321
- Recruiting
Research Site
Tampa, Florida, 33606
- Recruiting
Research Site
Tampa, Florida, 33607
- Recruiting
Research Site
Tulsa, Oklahoma, 74133
- Terminated
Research Site
Tustin, California, 92780
- Withdrawn
Research Site
West Des Moines, Iowa, 50266
- Recruiting
Research Site
Williamsburg, Virginia, 23188
- Recruiting
Research Site
Winter Park, Florida, 32789
- Recruiting
Research Site
Zachary, Louisiana, 70791
Japan38 sites, 37 recruiting
- Recruiting
Research Site
Chiba, 260-0852
- Recruiting
Research Site
Fukuoka, 814-0180
- Recruiting
Research Site
Fukushima, 960-1295
- Recruiting
Research Site
Ginowan-shi, 901-2214
- Recruiting
Research Site
Hachioji-shi, 193-0998
- Recruiting
Research Site
Hamamatsu, 431-3192
- Recruiting
Research Site
Hiroshima, 734-8530
- Recruiting
Research Site
Izumi-shi, 594-0073
- Recruiting
Research Site
Kamakura, 247-8533
- Recruiting
Research Site
Kanazawa, 920-8650
- Recruiting
Research Site
Kasuga-shi, 816-0813
- Recruiting
Research Site
Kawasaki-shi, 216-8511
- Recruiting
Research Site
Kiyosu-shi, 452-0001
- Recruiting
Research Site
Kochi, 780-8077
- Recruiting
Research Site
Kōtoku, 136-0075
- Withdrawn
Research Site
Kumamoto, 861-8520
- Not yet recruiting
Research Site
Kusatsu-shi, 525-8585
- Recruiting
Research Site
Kyoto, 612-8555
- Recruiting
Research Site
Maebashi, 371-8511
- Recruiting
Research Site
Matsuyama, 790-8524
- Recruiting
Research Site
Minoh, 562-0003
- Recruiting
Research Site
Minokamo Shi, 505-8510
- Recruiting
Research Site
Miura, 238-0111
- Recruiting
Research Site
Mizunami-shi, 509-6134
- Recruiting
Research Site
Ōita, 870-0033
- Recruiting
Research Site
Osaka, 545-8586
- Recruiting
Research Site
Sagamihara-shi, 252-0143
- Recruiting
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Sapporo, 063-0005
- Recruiting
Research Site
Sasebo-shi, 857-8511
- Recruiting
Research Site
Shimotsuga-gun, 321-0293
- Recruiting
Research Site
Shinjuku-ku, 160-0023
- Recruiting
Research Site
Tachikawa-shi, 190-8531
- Recruiting
Research Site
Toon-shi, 791-0281
- Recruiting
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Toyota, 471-0062
- Recruiting
Research Site
Ube, 755-8505
- Recruiting
Research Site
Yokkaichi-shi, 510-8561
- Recruiting
Research Site
Yokohama, 227-8501
- Recruiting
Research Site
Yokohama, 245-8575
China30 sites, 29 recruiting
- Recruiting
Research Site
Baotou, 014040
- Recruiting
Research Site
Beijing, 100024
- Recruiting
Research Site
Beijing, 100029
- Recruiting
Research Site
Beijing, 101100
- Recruiting
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Changchun, 130021
- Recruiting
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Changsha, 410008
- Recruiting
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Changsha, 410015
- Recruiting
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Chengdu, 610021
- Recruiting
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Chengdu, 610041
- Recruiting
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Chengdu, 610072
- Recruiting
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Chongqing, 400042
- Withdrawn
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Fuzhou, 350031
- Recruiting
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Guangzhou, 510163
- Recruiting
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Guangzhou, 510280
- Recruiting
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Hangzhou, 310009
- Recruiting
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Hohhot, 010050
- Recruiting
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Jinan, 250013
- Recruiting
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Kunming, 650032
- Recruiting
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Linhai, 317000
- Recruiting
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Nanchang, 330006
- Recruiting
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Nanjing, 210006
- Recruiting
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Nanning, 530021
- Recruiting
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Qingdao, 266011
- Recruiting
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Shanghai, 200025
- Recruiting
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Shanghai, 200433
- Recruiting
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Shenyang, 110004
- Recruiting
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Wuhan, 430030
- Recruiting
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Wuhan, 430060
- Recruiting
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Xuzhou, 221000
- Recruiting
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Zhengzhou, 450003
Germany20 sites, 19 recruiting
- Withdrawn
Research Site
Ahrensburg, 22926
- Recruiting
Research Site
Bendorf, 56170
- Recruiting
Research Site
Berlin, 10119
- Recruiting
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Berlin, 10787
- Recruiting
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Berlin, 10961
- Recruiting
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Berlin, 12157
- Recruiting
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Berlin, 12159
- Recruiting
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Berlin, 13187
- Recruiting
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Darmstadt, 64283
- Recruiting
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Halle, 06108
- Recruiting
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Hanover, D-30173
- Recruiting
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Landsberg, 86899
- Recruiting
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Leipzig, 04347
- Recruiting
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Lübeck, 23552
- Recruiting
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Marburg, 35037
- Recruiting
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Obertshausen, 63179
- Recruiting
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Rosenheim, 83022
- Recruiting
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Schleswig, 24837
- Recruiting
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Wiesbaden, 65183
- Recruiting
Research Site
Witten, 58452
Poland19 sites
- Active, not recruiting
Research Site
Bialystok, 15-044
- Active, not recruiting
Research Site
Bydgoszcz, 85-796
- Active, not recruiting
Research Site
Chęciny, 26-060
- Active, not recruiting
Research Site
Elblag, 82-300
- Active, not recruiting
Research Site
Karczew, 05-480
- Active, not recruiting
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Katowice, 40-081
- Active, not recruiting
Research Site
Katowice, 40-648
- Withdrawn
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Komorniki, 62-052
- Active, not recruiting
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Ksawerów, 95-054
- Active, not recruiting
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Lodz, 92-213
- Active, not recruiting
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Ostróda, 14-100
- Active, not recruiting
Research Site
Piaseczno, 05-500
- Terminated
Research Site
Piaseczno, 05-500
- Active, not recruiting
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Płock, 09-407
- Active, not recruiting
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Poznan, 60-693
- Active, not recruiting
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Rzeszów, 35-205
- Withdrawn
Research Site
Sosnowiec, 41-208
- Withdrawn
Research Site
Szczecin, 71-434
- Completed
Research Site
Warsaw, 00-719
Canada15 sites, 14 recruiting
- Recruiting
Research Site
Ajax, Ontario, L1S 2J5
- Recruiting
Research Site
Burlington, Ontario, L7N 3V2
- Withdrawn
Research Site
Edmonton, Alberta, T6G 2G3
- Recruiting
Research Site
Guelph, Ontario, N1H 6J2
- Recruiting
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Hamilton, Ontario, L8L 5G4
- Recruiting
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Québec, Quebec, G1V 4G5
- Recruiting
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Saint-Charles-Borromée, Quebec, J6E 2B4
- Recruiting
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Saskatoon, Saskatchewan, S7N 0W8
- Recruiting
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Sherbrooke, Quebec, J1H 5N4
- Recruiting
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Stoney Creek, Ontario, L8G 2V6
- Recruiting
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Trois-Rivières, Quebec, G8T 7A1
- Recruiting
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Trois-Rivières, Quebec, G9A 4P3
- Recruiting
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Truro, Nova Scotia, B2N 1L2
- Recruiting
Research Site
Victoriaville, Quebec, G6P 3Z8
- Recruiting
Research Site
Winnipeg, Manitoba, R3L 1Z5
South Korea14 sites, 14 recruiting
- Recruiting
Research Site
Anyang-si, 14068
- Recruiting
Research Site
Cheongju-si, 28644
- Recruiting
Research Site
Chuncheon, 200-704
- Recruiting
Research Site
Daegu, 42415
- Recruiting
Research Site
Daegu, 42601
- Recruiting
Research Site
Jeonju, 54907
- Recruiting
Research Site
Seongnam-si, 13520
- Recruiting
Research Site
Seoul, 03181
- Recruiting
Research Site
Seoul, 06591
- Recruiting
Research Site
Seoul, 07061
- Recruiting
Research Site
Seoul, 08308
- Recruiting
Research Site
Seoul, 143-729
- Recruiting
Research Site
Seoul, 150-713
- Recruiting
Research Site
Wŏnju, 26426
Argentina11 sites, 10 recruiting
- Recruiting
Research Site
Alberdi, X5033DCE
- Recruiting
Research Site
CABA, C1426
- Recruiting
Research Site
Ciudad Autónoma de Bs As, C1182ACD
- Recruiting
Research Site
Ciudad de Buenos Aires, 1060
- Withdrawn
Research Site
Ciudad de Buenos Aires, C1094AAD
- Recruiting
Research Site
Mar del Plata, 7600
- Recruiting
Research Site
Mar del Plata, B7600GWV
- Recruiting
Research Site
Mendoza, M5500CCG
- Recruiting
Research Site
Ranelagh, 1886
- Recruiting
Research Site
Rosario, 2000
- Recruiting
Research Site
San Miguel de Tucumán, 4000
Hungary11 sites, 8 recruiting
- Recruiting
Research Site
Balassagyarmat, 2660
- Recruiting
Research Site
Budapest, 1044
- Recruiting
Research Site
Debrecen, 4032
- Withdrawn
Research Site
Edelény, 3780
- Withdrawn
Research Site
Encs, 3860
- Recruiting
Research Site
Gödöllő, 2100
- Recruiting
Research Site
Hajdúnánás, 4080
- Withdrawn
Research Site
Nyíregyháza-Sóstóhegy, 4481
- Recruiting
Research Site
Pécs, 7635
- Recruiting
Research Site
Szombathely, 9700
- Recruiting
Research Site
Törökbálint, 2045
India11 sites, 10 recruiting
- Recruiting
Research Site
Belagavi, 590010
- Recruiting
Research Site
Coimbatore, 641028
- Recruiting
Research Site
Dehradun, 248001
- Recruiting
Research Site
Delhi, 110029
- Recruiting
Research Site
Dwārka, 110075
- Suspended
Research Site
Hyderabad, 500055
- Recruiting
Research Site
Hyderabad, 500068
- Recruiting
Research Site
Kochi, 682018
- Recruiting
Research Site
Mumbai, 400008
- Recruiting
Research Site
Nagpur, 440019
- Recruiting
Research Site
Vijayawada, 520 008
Ukraine11 sites, 11 recruiting
- Recruiting
Research Site
Chernivtsi, 58029
- Recruiting
Research Site
Ivano-Frankivsk, 76018
- Recruiting
Research Site
Ivano-Frankivsk, 76019
- Recruiting
Research Site
Kyiv, 02002
- Recruiting
Research Site
Kyiv, 02081
- Recruiting
Research Site
Kyiv, 02091
- Recruiting
Research Site
Kyiv, 03037
- Recruiting
Research Site
Kyiv, 03680
- Recruiting
Research Site
Lutsk, 43000
- Recruiting
Research Site
Ternopil, 46000
- Recruiting
Research Site
Uzhhorod, 88018
Italy10 sites, 9 recruiting
- Recruiting
Research Site
Busto Arsizio, 21052
- Recruiting
Research Site
Cuneo, 12100
- Recruiting
Research Site
Ferrara, 44100
- Withdrawn
Research Site
Milan, 20122
- Recruiting
Research Site
Monza, 20900
- Recruiting
Research Site
Naples, 80131
- Recruiting
Research Site
Pavia, 27100
- Recruiting
Research Site
Roma, 00161
- Recruiting
Research Site
Statte, 74010
- Recruiting
Research Site
Telese Terme, 82037
Mexico10 sites, 8 recruiting
- Recruiting
Research Site
Chihuahua City, 31210
- Recruiting
Research Site
Durango, 34000
- Recruiting
Research Site
Guadalajara, 44100
- Withdrawn
Research Site
Guadalajara, 44200
- Recruiting
Research Site
Mexico City, 04100
- Recruiting
Research Site
Mexico City, 14050
- Withdrawn
Research Site
Monterrey, 64060
- Recruiting
Research Site
Monterrey, 64460
- Recruiting
Research Site
Monterrey, 64465
- Not yet recruiting
Research Site
Monterrey, 64710
Taiwan10 sites, 10 recruiting
- Recruiting
Research Site
Changhua, 500
- Recruiting
Research Site
Kaohsiung City, 80756
- Recruiting
Research Site
Kaohsiung City, 824
- Recruiting
Research Site
Taichung, 40447
- Recruiting
Research Site
Taichung, 40705
- Recruiting
Research Site
Taichung, 433004
- Recruiting
Research Site
Taipei, 10002
- Recruiting
Research Site
Taipei, 11696
- Recruiting
Research Site
Taoyuan, 333
- Recruiting
Research Site
Yung Kang City, 71044
United Kingdom9 sites, 5 recruiting
- Completed
Research Site
Bradford, BD9 6RJ
- Recruiting
Research Site
Cottingham, HU16 5JQ
- Recruiting
Research Site
Glasgow, G4 0SF
- Active, not recruiting
Research Site
Harrow, HA1 3UJ
- Recruiting
Research Site
London, EC1M 6BQ
- Completed
Research Site
London, NW3 2QG
- Recruiting
Research Site
Newcastle upon Tyne, NE1 4LP
- Recruiting
Research Site
Thetford, IP24 1JD
- Active, not recruiting
Research Site
Wythenshawe, M23 9QZ
Chile8 sites, 7 recruiting
- Recruiting
Research Site
Chile, 7770484
- Recruiting
Research Site
Concepción, 4070057
- Suspended
Research Site
Santiago, 7501126
- Recruiting
Research Site
Santiago, 7750495
- Recruiting
Research Site
Santiago, 8380453
- Recruiting
Research Site
Talca, 3481349
- Recruiting
Research Site
Temuco, 4810345
- Recruiting
Research Site
Viña del Mar, 2540488
Peru8 sites, 7 recruiting
- Recruiting
Research Site
Lima, 15024
- Recruiting
Research Site
Lima, 15036
- Recruiting
Research Site
Lima, 15082
- Withdrawn
Research Site
Lima, 15088
- Not yet recruiting
Research Site
Lima, 15102
- Recruiting
Research Site
Lima, 15324
- Recruiting
Research Site
Lima, LIMA 1
- Recruiting
Research Site
Lima, Lima 33
Vietnam8 sites, 8 recruiting
- Recruiting
Research Site
Da Nang, 55000
- Not yet recruiting
Research Site
Dong Thập, 83000
- Recruiting
Research Site
Hà Nội, 100000
- Recruiting
Research Site
Hanoi, 100000
- Recruiting
Research Site
Hanoi, 10000
- Recruiting
Research Site
Ho Chi Minh City, 700000
- Recruiting
Research Site
Huế, 530000
- Recruiting
Research Site
Rach Gia, 920000
Bulgaria7 sites
- Completed
Research Site
Dupnitsa, 2600
- Active, not recruiting
Research Site
Haskovo, 6300
- Completed
Research Site
Plovdiv, 4003
- Active, not recruiting
Research Site
Sofia, 1756
- Active, not recruiting
Research Site
Stara Zagora, 6003
- Active, not recruiting
Research Site
Veliko Tarnovo, 5000
- Completed
Research Site
Yambol, 8600
Spain7 sites, 7 recruiting
- Recruiting
Research Site
Benalmádena, 29631
- Recruiting
Research Site
Granollers, 08402
- Recruiting
Research Site
Madrid, 28007
- Recruiting
Research Site
Málaga, 29010
- Recruiting
Research Site
Mérida, 06800
- Recruiting
Research Site
Pozuelo de Alarcón, 28223
- Recruiting
Research Site
Santander, 39008
Australia6 sites, 5 recruiting
- Completed
Research Site
Cairns, 4870
- Recruiting
Research Site
Nedlands, 6009
- Recruiting
Research Site
Norwood, 5067
- Recruiting
Research Site
Osborne Park, 6017
- Recruiting
Research Site
South Brisbane, 4101
- Recruiting
Research Site
Wollongong, 2500
Denmark6 sites, 6 recruiting
- Recruiting
Research Site
Aalborg, 9000
- Recruiting
Research Site
Aarhus, 8200
- Recruiting
Research Site
Esbjerg, 6700
- Recruiting
Research Site
Hvidovre, 2650
- Recruiting
Research Site
Odense C, 5000
- Recruiting
Research Site
Roskilde, 4000
Greece6 sites, 6 recruiting
- Recruiting
Research Site
Athens, 11521
- Recruiting
Research Site
Athens, 11527
- Recruiting
Research Site
Athens, 17562
- Recruiting
Research Site
Ioannina, 45500
- Recruiting
Research Site
Thessaloniki, 57001
- Recruiting
Research Site
Thessaloniki, 57010
Turkey (Türkiye)6 sites, 6 recruiting
- Recruiting
Research Site
Adana, 1330
- Recruiting
Research Site
Ankara, 06530
- Recruiting
Research Site
Bursa, 16059
- Recruiting
Research Site
İzmit, 41380
- Recruiting
Research Site
Kayseri, 38039
- Recruiting
Research Site
Mersin, 33343
About this study
Official title: 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)
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.
Read the 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.
- Being tested
- AZD6793, Placebo
- Keywords
- COPD, Moderate COPD, Severe COPD, Very Severe COPD, chronic obstructive pulmonary disease, AZD6793, IRAK4 Inhibitor
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6793Drug
Oral dosage
PlaceboOther
Oral dosage
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 of AZD6793 | Experimental | Approximately 290 participants will be randomized to receive Dose 1 of AZD6793 Receives: Drug: AZD6793 |
| Dose 2 of AZD6793 | Experimental | Approximately 290 participants will be randomized to receive Dose 2 of AZD6793 Receives: Drug: AZD6793 |
| Matching Placebo | Placebo comparator | Approximately 290 participants will be randomized to receive Matching Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualised rate of moderate or severe COPD exacerbations
The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 24 Weeks treatment period compared to placebo
Measured: From baseline up to 24 Weeks
Secondary outcomes (11)
Time to first moderate or severe COPD exacerbation
To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks
Measured: From baseline up to 24 Weeks
Annualised rate of COPD exacerbations associated with emergency room visits, urgent care visits, or hospitalisations
To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks
Measured: From baseline up to 24 Weeks
Annualised rate of severe COPD exacerbations
To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks
Measured: From baseline up to 24 Weeks
Annualised rate of COPDCompEx events
To evaluate the effect of AZD6793 as compared to placebo on COPDCompEx events from baseline up to 24 Weeks
Measured: From baseline up to 24 Weeks
Time to first COPDCompEx event
To evaluate the effect of AZD6793 as compared to placebo on COPDCompEx events from baseline up to 24 Weeks
Measured: From baseline up to 24 Weeks
Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)
Change from baseline in pre-BD FEV1 at Week 12 and Week 24 compared to placebo
Measured: From baseline to Week 12 and Week 24
Change from baseline in post-bronchodilator (post-BD) forced expiratory volume in 1 second (FEV1)
Change from baseline in post-BD FEV1 at Week 12 and Week 24 compared to placebo
Measured: From baseline to Week 12 and Week 24
Change from baseline in Breathlessness, Cough and Sputum Scale (BCSS) total score
Change from baseline in BCSS total score over 24 Weeks compared to placebo.
The BCSS is a 3-item questionnaire rating breathlessness, sputum, and cough on a 5 point Likert scale from 0 (no symptoms) to 4 (severe symptoms). The BCSS has a scoring range of 0-12 with higher scores indicative of greater COPD impact on health status.
Measured: From baseline over 24 Weeks
Change from baseline in COPD Assessment Test (CAT) total score
Change from baseline in the CAT total score over 24 weeks
CAT is an 8-item PRO that measures the impact of COPD on the health status of patients with COPD. The CAT has a scoring range of 0-40 with higher scores indicative of greater COPD impact on health status.
Measured: From baseline over 24 Weeks
Change from baseline in St George's Respiratory Questionnaire (SGRQ) total and domain scores
Participants achieving a clinically meaningful improvement from baseline in SGRQ total score (4-point score decrease) over 24 weeks.
SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating better health status.
Measured: From baseline over 24 Weeks
Measurement of plasma concentrations of AZD6793 at specific timepoints
To assess the pharmacokinetics (PK) of AZD6793 in participants with moderate to very severe COPD
Measured: From baseline to Week 4, Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start27 Jun 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a ratio of 1:1:1 to receive Dose 1 of AZD6793, Dose 2 of AZD6793 or matching placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 987 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Singh, MD, Principal investigator, Medicines Evaluation Unit, Manchester University NHS Foundations Trust, Manchester, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082738
- Sponsor's protocol ID
- D7860C00006
- Acronym
- PRESTO
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.