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Sponsor: Pfizer
Conditions: Moderate to Severe Chronic Obstructive Pulmonary Disease
Interventions: PF-07275315 dose 1, PF-07275315-dose 2, Placebo, PF-07275315-dose 3
Countries: United States, Argentina, Canada, China, India, Japan, South Korea, Taiwan
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.
Sex: ALL
Age: 35 Years to 80 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Key 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. Key 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.
- Birmingham, Alabama, United States
- Dothan, Alabama, United States
- Mobile, Alabama, United States
- Chandler, Arizona, United States
- Phoenix, Arizona, United States
- La Palma, California, United States
- Newport Beach, California, United States
- Northridge, California, United States
- San Diego, California, United States
- Greenacres City, Florida, United States
- Kissimmee, Florida, United States
- Loxahatchee Groves, Florida, United States
- Miami, Florida, United States
- Ocala, Florida, United States
- Ocala, Florida, United States
- Ocala, Florida, United States
- Ocala, Florida, United States
- St. Petersburg, Florida, United States
- St. Petersburg, Florida, United States
- Tampa, Florida, United States
- Winter Park, Florida, United States
- East Point, Georgia, United States
- Rincon, Georgia, United States
- Hammond, Indiana, United States
- Merrillville, Indiana, United States
- Zachary, Louisiana, United States
- Bangor, Maine, United States
- Fall River, Massachusetts, United States
- Dearborn, Michigan, United States
- Flint, Michigan, United States
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