A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Purpose
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.
Condition
- Chronic Obstructive Pulmonary Disease (COPD)
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention 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.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Double-blinded
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dose 1 of AZD6793 |
Approximately 290 participants will be randomized to receive Dose 1 of AZD6793 |
|
|
Experimental Dose 2 of AZD6793 |
Approximately 290 participants will be randomized to receive Dose 2 of AZD6793 |
|
|
Placebo Comparator Matching Placebo |
Approximately 290 participants will be randomized to receive Matching Placebo |
|
Recruiting Locations
Research Site
Birmingham, Alabama 35205
Birmingham, Alabama 35205
Research Site
Phoenix, Arizona 85027
Phoenix, Arizona 85027
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Phoenix, Arizona 85044
Phoenix, Arizona 85044
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Phoenix, Arizona 85051
Phoenix, Arizona 85051
Research Site
Los Angeles, California 90017
Los Angeles, California 90017
Research Site
Newport Beach, California 92663
Newport Beach, California 92663
Research Site
Norco, California 92860
Norco, California 92860
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Tustin, California 92780
Tustin, California 92780
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Brandon, Florida 33511
Brandon, Florida 33511
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Cape Coral, Florida 33990
Cape Coral, Florida 33990
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Clearwater, Florida 33756
Clearwater, Florida 33756
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Clearwater, Florida 33765
Clearwater, Florida 33765
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Lake City, Florida 32055
Lake City, Florida 32055
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Miami, Florida 33125
Miami, Florida 33125
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Miami, Florida 33155
Miami, Florida 33155
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Miami, Florida 33173
Miami, Florida 33173
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Miami, Florida 33175
Miami, Florida 33175
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Miami, Florida 33182
Miami, Florida 33182
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Miami Lakes, Florida 33016
Miami Lakes, Florida 33016
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Naples, Florida 34102
Naples, Florida 34102
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Ocala, Florida 34471
Ocala, Florida 34471
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Ormond Beach, Florida 32174
Ormond Beach, Florida 32174
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Plantation, Florida 33324
Plantation, Florida 33324
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Sarasota, Florida 34239
Sarasota, Florida 34239
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Tamarac, Florida 33321
Tamarac, Florida 33321
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Tampa, Florida 33606
Tampa, Florida 33606
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Tampa, Florida 33607
Tampa, Florida 33607
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Winter Park, Florida 32789
Winter Park, Florida 32789
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Suwanee, Georgia 30024
Suwanee, Georgia 30024
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Zachary, Louisiana 70791
Zachary, Louisiana 70791
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Baltimore, Maryland 21201
Baltimore, Maryland 21201
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Baltimore, Maryland 21224
Baltimore, Maryland 21224
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Burlington, Massachusetts 01805
Burlington, Massachusetts 01805
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Farmington Hills, Michigan 48336
Farmington Hills, Michigan 48336
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Garden City, Michigan 48135
Garden City, Michigan 48135
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Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
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Chesterfield, Missouri 63005
Chesterfield, Missouri 63005
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Hannibal, Missouri 63401
Hannibal, Missouri 63401
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St Louis, Missouri 63110
St Louis, Missouri 63110
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St Louis, Missouri 63141
St Louis, Missouri 63141
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Kalispell, Montana 59901
Kalispell, Montana 59901
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Mount Kisco, New York 10549
Mount Kisco, New York 10549
Research Site
New Bern, North Carolina 28562
New Bern, North Carolina 28562
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Cleveland, Ohio 44106
Cleveland, Ohio 44106
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Marion, Ohio 43302
Marion, Ohio 43302
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Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
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Tulsa, Oklahoma 74133
Tulsa, Oklahoma 74133
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Medford, Oregon 97504
Medford, Oregon 97504
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Portland, Oregon 97202
Portland, Oregon 97202
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Camp Hill, Pennsylvania 17011
Camp Hill, Pennsylvania 17011
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DuBois, Pennsylvania 15801
DuBois, Pennsylvania 15801
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Philadelphia, Pennsylvania 19114
Philadelphia, Pennsylvania 19114
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Philadelphia, Pennsylvania 19140
Philadelphia, Pennsylvania 19140
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Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
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Scottdale, Pennsylvania 15683
Scottdale, Pennsylvania 15683
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Smithfield, Pennsylvania 15478
Smithfield, Pennsylvania 15478
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Lancaster, South Carolina 29720
Lancaster, South Carolina 29720
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Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29303
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Rapid City, South Dakota 57702
Rapid City, South Dakota 57702
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Chattanooga, Tennessee 37421
Chattanooga, Tennessee 37421
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Franklin, Tennessee 37067
Franklin, Tennessee 37067
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Boerne, Texas 78006
Boerne, Texas 78006
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Dallas, Texas 75254
Dallas, Texas 75254
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Denison, Texas 75020
Denison, Texas 75020
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El Paso, Texas 79902
El Paso, Texas 79902
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Houston, Texas 77002
Houston, Texas 77002
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Houston, Texas 77008
Houston, Texas 77008
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Kingwood, Texas 77339
Kingwood, Texas 77339
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Lewisville, Texas 75067
Lewisville, Texas 75067
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Mansfield, Texas 76063
Mansfield, Texas 76063
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McKinney, Texas 75069
McKinney, Texas 75069
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Colchester, Vermont 05446
Colchester, Vermont 05446
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Norfolk, Virginia 23504
Norfolk, Virginia 23504
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Williamsburg, Virginia 23188
Williamsburg, Virginia 23188
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Morgantown, West Virginia 26505
Morgantown, West Virginia 26505
Research Site
Madison, Wisconsin 53715
Madison, Wisconsin 53715
More Details
- Status
- Recruiting
- Sponsor
- AstraZeneca
Study Contact
AstraZeneca Clinical Study Information Center1-877-240-9479
information.center@astrazeneca.com
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.