A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease
Purpose
The purpose of this clinical trial is to learn about the effects and safety of the study medicine PF-07275315 for the potential treatment of COPD. COPD is a condition that makes it difficult to breathe, which negatively impacts the quality of life and functioning of people who are affected. This study is seeking participants who: - Are 35 to 80 years old - Have had moderate-to-severe COPD for at least 12 months - Have a documented history of at least 2 moderate or severe exacerbations within the last 12 months - Have been continuously taking their regular maintenance treatment(s) for COPD over at least 6 months at a stable dose for 3 months All participants will receive PF-07275315 or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-07275315 or placebo will be given as multiple shots in the clinic over the course of 24 weeks for the Phase 2 part and 52 weeks for the Phase 3 part. We will compare the results of people receiving PF-07275315 to those of the people who do not. This will help us determine if PF-07275315 is safe and effective. Participants who will be involved in the Phase 2 part of the study for about 40 weeks. During this time, they will have 11 visits at the study clinic. Participants who will be involved in the Phase 3 part of the study for about 68 weeks. During this time, they will have 18 visits at the study clinic.
Condition
- Moderate to Severe Chronic Obstructive Pulmonary Disease
Eligibility
- Eligible Ages
- Between 35 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Diagnosis of chronic obstructive pulmonary disease (COPD) for at least 12 months (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition). - Spirometry values (post-bronchodilator forced expiratory volume in 1 second [FEV1]/forced vital capacity [FVC] less than [<] 70 percent (%) and post-bronchodilator FEV1 % predicted <70%, but greater than equal to 30%). - Continuous treatment with standard of care triple therapy of LABA + LAMA + ICS for ≥ 6 months prior to Screening Visit 1 and at a stable dose for ≥3 months - Documented history of at least 2 moderate or severe ECOPD within the last 12 months prior to Screening.
Exclusion Criteria
- Significant pulmonary disease other than COPD. - Requirement for continuous chronic treatment with oxygen at >4.0 liters / minute by nasal cannula or equivalent. - Hypoxemia with a resting SpO2 <88% while breathing ambient air (or on the participant's usual level of oxygen supplementation). - Clinically significant cardiovascular disease, acute and/or severe left heart failure, or heart failure partial ejection fraction, and/or cor pulmonale.
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- All dosing syringes will be masked and an unblinded administrator will administer the study intervention.
Arm Groups
| Arm | Description | Assigned Intervention |
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Experimental Phase 2 Treatment Arm A |
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Experimental Phase 2 Treatment Arm B |
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Placebo Comparator Phase 2 Treatment Arm C |
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Experimental Phase 3 Treatment Arm A |
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Placebo Comparator Phase 3 Treatment Arm B |
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Recruiting Locations
Birmingham, Alabama 35233
Dothan, Alabama 36305
Mobile, Alabama 36608
Phoenix, Arizona 85027
La Palma, California 90623
Newport Beach, California 92663
Northridge, California 91324
San Diego, California 92120
Greenacres City, Florida 33467
Loxahatchee Groves, Florida 33470
Miami, Florida 33176
Ocala, Florida 34470
Ocala, Florida 34471
Ocala, Florida 34471
St. Petersburg, Florida 33704
St. Petersburg, Florida 33704
Winter Park, Florida 32789
East Point, Georgia 30344
Rincon, Georgia 31326
Hammond, Indiana 46324
Merrillville, Indiana 46410
Dearborn, Michigan 48126
Flint, Michigan 48504
Southfield, Michigan 48075
St Louis, Missouri 63108
St Louis, Missouri 63110
St Louis, Missouri 63110
St Louis, Missouri 63110
St Louis, Missouri 63110
Henderson, Nevada 89052
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
DuBois, Pennsylvania 15801
Gaffney, South Carolina 29340
Rock Hill, South Carolina 29732
Spartanburg, South Carolina 29303
Rapid City, South Dakota 57702
Franklin, Tennessee 37067
Hendersonville, Tennessee 37075
Carrollton, Texas 75010
Cypress, Texas 77429
Dallas, Texas 75209
Houston, Texas 77008
Houston, Texas 77065
Sherman, Texas 75090
More Details
- Status
- Recruiting
- Sponsor
- Pfizer