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A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease

NCT07363694 · Pfizer
In plain English

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Official title
AN INTERVENTIONAL PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY-UNBLINDED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
About this study
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 \[\<\] 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.
Study design
Enrollment target: 1156 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2026-02-11
Estimated completion: 2031-01-16
Last updated: 2026-03-27
Interventions
Drug: PF-07275315 dose 1Drug: PF-07275315-dose 2Drug: PlaceboDrug: PF-07275315-dose 3
Primary outcomes
  • Phase 2 part: Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline to Week 24)
  • Phase 3 part: Annualized rate of moderate or severe ECOPD (Baseline to Week 52)
Sponsor
Pfizer · industry
Contacts & investigators
ContactPfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021
InvestigatorPfizer CT.gov Call Center · study_director, Pfizer
All locations (32)
SEC Clinical ResearchNot Yet Recruiting
Dothan, Alabama, United States
Pulmonary Associates of Mobile, P.C.Not Yet Recruiting
Mobile, Alabama, United States
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Chandler, Arizona, United States
Pulmonary Associates, PARecruiting
Phoenix, Arizona, United States
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La Palma, California, United States
NewportNativeMD, Inc.Recruiting
Newport Beach, California, United States
California Medical Research AssociatesNot Yet Recruiting
Northridge, California, United States
Institute of HealthCare Assessment d/b/a Apex Clinical ResearchRecruiting
San Diego, California, United States
Advanced Pulmonary Research InstituteRecruiting
Loxahatchee Groves, Florida, United States
Reed Medical ResearchRecruiting
Miami, Florida, United States
Coastal Medical Research Institute, LLCNot Yet Recruiting
St. Petersburg, Florida, United States
Coastal Pulmonary and Critical Care, P.L.CNot Yet Recruiting
St. Petersburg, Florida, United States
Cpcc-Research LlcRecruiting
East Point, Georgia, United States
Centricity Research Rincon PulmonologyRecruiting
Rincon, Georgia, United States
ASHA Clinical Research - Munster, LLCNot Yet Recruiting
Hammond, Indiana, United States
Methodist Hospital SouthlakeNot Yet Recruiting
Merrillville, Indiana, United States
Paul A. Shapero, MD, PANot Yet Recruiting
Bangor, Maine, United States
Revival Research Institute, LLCRecruiting
Dearborn, Michigan, United States
Revive Research Institute, Inc.Recruiting
Southfield, Michigan, United States
Henderson Clinical TrialsNot Yet Recruiting
Henderson, Nevada, United States
Salem Chest SpecialistsRecruiting
Winston-Salem, North Carolina, United States
Southeastern Research CenterRecruiting
Winston-Salem, North Carolina, United States
Toledo Institute of Clinical Research Inc.Not Yet Recruiting
Toledo, Ohio, United States
Clinical Research Associates of Central PA, LLCRecruiting
DuBois, Pennsylvania, United States
Velocity Clinical Research, GaffneyRecruiting
Gaffney, South Carolina, United States
Clinical Research of Rock HillRecruiting
Rock Hill, South Carolina, United States
Velocity Clinical Research, SpartanburgRecruiting
Spartanburg, South Carolina, United States
Health ConceptsNot Yet Recruiting
Rapid City, South Dakota, United States
Premier Research Center, LLCRecruiting
Hendersonville, Tennessee, United States
Sherman Clinical ResearchNot Yet Recruiting
Sherman, Texas, United States
Dr. Syed Anees Medicine Professional CorporationRecruiting
Windsor, Ontario, Canada
Nishifukuoka HospitalNot Yet Recruiting
Fukuoka, Fukuoka, Japan
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate to Severe Chronic Obstructive Pulmonary Disease · TrialPath