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Recruiting
NCT07363694
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease
Conditions: Moderate to Severe Chronic Obstructive Pulmonary Disease
Sex: All
Ages: 35 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 1156
Sponsor: Pfizer
Location: University of Alabama at Birmingham Lung Health Center Birmingham Alabama
Summary
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.
Eligibility Criteria
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 \[\
Source: ClinicalTrials.gov (NCT07363694). StuddyBuddy aggregates publicly available trial information.