PF-07275315 for people with moderate to severe COPD
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)
This study will test whether PF-07275315, given as clinic injections, helps people aged 35–80 with moderate to severe COPD who have frequent exacerbations while on standard triple inhaled therapy.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1156 (estimated) |
| Ages | 35 Years to 80 Years |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 32 sites (Dothan, Alabama and 31 other locations) |
| Trial ID | NCT07363694 on ClinicalTrials.gov |
What this trial studies
This phase 2/3, randomized, placebo-controlled study gives PF-07275315 or placebo as multiple injections over 24 weeks (phase 2) or 52 weeks (phase 3) and compares outcomes to placebo. Eligible participants have had moderate-to-severe COPD for at least 12 months, a history of two or more moderate/severe exacerbations in the prior year, and are on stable LABA+LAMA+ICS therapy. The trial monitors safety and clinical outcomes over the treatment period to see if the medicine reduces exacerbations or improves lung function and symptoms. Standard exclusion criteria include other significant pulmonary diseases and severe resting hypoxemia or need for continuous high-flow oxygen.
Who should consider this trial
Good fit: Ideal candidates are adults 35–80 years old with moderate-to-severe COPD for ≥12 months, at least two documented moderate or severe exacerbations in the past year, and on stable triple inhaled therapy (LABA+LAMA+ICS) for ≥6 months with stable dosing for ≥3 months.
Not a fit: People with mild COPD, significant other lung diseases, resting SpO2 <88% on room air, or who require continuous oxygen >4 L/min are unlikely to benefit or be eligible for this trial.
Why it matters
Potential benefit: If successful, PF-07275315 could reduce the number or severity of COPD exacerbations and improve breathing and daily functioning for people with frequent exacerbations.
How similar studies have performed: PF-07275315 is an investigational therapy and the approach is relatively novel in COPD, with limited published evidence of clear benefit to date.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dothan, Alabama and 31 other locations
- SEC Clinical Research — Dothan, Alabama, United States (Not_yet_recruiting)
- Pulmonary Associates of Mobile, P.C. — Mobile, Alabama, United States (Not_yet_recruiting)
- Chandler Clinical Trials — Chandler, Arizona, United States (Not_yet_recruiting)
- Pulmonary Associates, PA — Phoenix, Arizona, United States (Recruiting)
- IMAX Clinical Trials — La Palma, California, United States (Not_yet_recruiting)
- NewportNativeMD, Inc. — Newport Beach, California, United States (Recruiting)
- California Medical Research Associates — Northridge, California, United States (Not_yet_recruiting)
- Institute of HealthCare Assessment d/b/a Apex Clinical Research — San Diego, California, United States (Recruiting)
- Advanced Pulmonary Research Institute — Loxahatchee Groves, Florida, United States (Recruiting)
- Reed Medical Research — Miami, Florida, United States (Recruiting)
- Coastal Medical Research Institute, LLC — St. Petersburg, Florida, United States (Not_yet_recruiting)
- Coastal Pulmonary and Critical Care, P.L.C — St. Petersburg, Florida, United States (Not_yet_recruiting)
- Cpcc-Research Llc — East Point, Georgia, United States (Recruiting)
- Centricity Research Rincon Pulmonology — Rincon, Georgia, United States (Recruiting)
- ASHA Clinical Research - Munster, LLC — Hammond, Indiana, United States (Not_yet_recruiting)
- Methodist Hospital Southlake — Merrillville, Indiana, United States (Not_yet_recruiting)
- Paul A. Shapero, MD, PA — Bangor, Maine, United States (Not_yet_recruiting)
- Revival Research Institute, LLC — Dearborn, Michigan, United States (Recruiting)
- Revive Research Institute, Inc. — Southfield, Michigan, United States (Recruiting)
- Henderson Clinical Trials — Henderson, Nevada, United States (Not_yet_recruiting)
- Salem Chest Specialists — Winston-Salem, North Carolina, United States (Recruiting)
- Southeastern Research Center — Winston-Salem, North Carolina, United States (Recruiting)
- Toledo Institute of Clinical Research Inc. — Toledo, Ohio, United States (Not_yet_recruiting)
- Clinical Research Associates of Central PA, LLC — DuBois, Pennsylvania, United States (Recruiting)
- Velocity Clinical Research, Gaffney — Gaffney, South Carolina, United States (Recruiting)
- Clinical Research of Rock Hill — Rock Hill, South Carolina, United States (Recruiting)
- Velocity Clinical Research, Spartanburg — Spartanburg, South Carolina, United States (Recruiting)
- Health Concepts — Rapid City, South Dakota, United States (Not_yet_recruiting)
- Premier Research Center, LLC — Hendersonville, Tennessee, United States (Recruiting)
- Sherman Clinical Research — Sherman, Texas, United States (Not_yet_recruiting)
- Dr. Syed Anees Medicine Professional Corporation — Windsor, Ontario, Canada (Recruiting)
- Nishifukuoka Hospital — Fukuoka, Fukuoka, Japan (Not_yet_recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.