A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease
Recruiting · NCT07363694 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
60 locations listed across 21 US states.
- University of Alabama at Birmingham Lung Health Center - Birmingham, Alabama, United States
- SEC Clinical Research - Dothan, Alabama, United States
- Pulmonary Associates of Mobile, P.C. - Mobile, Alabama, United States
- Chandler Clinical Trials - Chandler, Arizona, United States
- Pulmonary Associates, PA - Phoenix, Arizona, United States
- IMAX Clinical Trials - La Palma, California, United States
- NewportNativeMD, Inc. - Newport Beach, California, United States
- California Medical Research Associates - Northridge, California, United States
- Institute of HealthCare Assessment d/b/a Apex Clinical Research - San Diego, California, United States
- Finlay Medical Research - Greenacres City, Florida, United States
- Clinical Research Specialists LLC - Kissimmee, Florida, United States
- Advanced Pulmonary Research Institute - Loxahatchee Groves, Florida, United States
- Reed Medical Research - Miami, Florida, United States
- Renstar Medical Research - Ocala, Florida, United States
- HCA Florida Ocala Imaging Center - Ocala, Florida, United States
- Ocala Lung and Critical Care Associates - Ocala, Florida, United States
- Renstar Medical Research - Ocala, Florida, United States
- Coastal Medical Research Institute, LLC - St. Petersburg, Florida, United States
- Coastal Pulmonary and Critical Care, P.L.C - St. Petersburg, Florida, United States
- Clinical Research Trials of Florida, Inc. - Tampa, Florida, United States
- Clinical Site Partners, LLC dba Flourish Research - Winter Park, Florida, United States
- Cpcc-Research Llc - East Point, Georgia, United States
- Centricity Research Rincon Pulmonology - Rincon, Georgia, United States
- ASHA Clinical Research - Munster, LLC - Hammond, Indiana, United States
- Methodist Hospital Southlake - Merrillville, Indiana, United States
- University of Kansas Medical Center - Kansas City, Kansas, United States
- Southern Clinical Research, LLC - Zachary, Louisiana, United States
- Paul A. Shapero, MD, PA - Bangor, Maine, United States
- Exordia Medical Research Inc. - Fall River, Massachusetts, United States
- Infinity Medical Research - North Dartmouth, Massachusetts, United States
- Revival Research Institute, LLC - Dearborn, Michigan, United States
- AA Medical Research Center - Flint, Michigan, United States
- Revive Research Institute, Inc. - Southfield, Michigan, United States
- Oakland Medical Research - Troy, Michigan, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Barnes-Jewish Hospital Investigational Drug Service - St Louis, Missouri, United States
- Barnes-Jewish Hospital - St Louis, Missouri, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Washington University School-Cardiovascular Imaging and Clinical Research Core Laboratory - St Louis, Missouri, United States
- Henderson Clinical Trials - Henderson, Nevada, United States
- Northwell Health Physician Partners at Chappaqua - Chappaqua, New York, United States
- New York Presbyterian Queens - Flushing, New York, United States
- Northern Westchester Hospital - Mount Kisco, New York, United States
- Salem Chest Specialists - Winston-Salem, North Carolina, United States
- Southeastern Research Center - Winston-Salem, North Carolina, United States
- Toledo Institute of Clinical Research Inc. - Toledo, Ohio, United States
- Clinical Research Associates of Central PA, LLC - DuBois, Pennsylvania, United States
- Bogan Sleep Consultants, LLC - Columbia, South Carolina, United States
- Velocity Clinical Research, Gaffney - Gaffney, South Carolina, United States
- Clinical Research of Rock Hill - Rock Hill, South Carolina, United States
- Velocity Clinical Research, Spartanburg - Spartanburg, South Carolina, United States
- Health Concepts - Rapid City, South Dakota, United States
- Clinical Trials Center of Middle Tennessee, LLC - Franklin, Tennessee, United States
- Premier Research Center, LLC - Hendersonville, Tennessee, United States
- South Texas Medical Research Institute, Inc., DBA TTS Research - Boerne, Texas, United States
- Ten20 Clinical Research - Carrollton, Texas, United States
- Horizon Clinical Research Group - Cypress, Texas, United States
- Alina Clinical Trials, LLC. - Dallas, Texas, United States
- Greater Heights & Memorial Pulmonary and Sleep - Houston, Texas, United States
- Houston Pulmonary Sleep and Allergy Associates - Houston, Texas, United States
Showing 60 of 120 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →