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
More Details
- Status
- Recruiting
- Sponsor
- Pfizer