Are you struggling with managing symptoms of Chronic Obstructive Pulmonary Disease (COPD)?
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.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your health to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others struggling with COPD, and whether it will be made widely available to all Canadians trying to manage this condition. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Have had a diagnosis of chronic obstructive pulmonary disease (COPD) for at least 12 months (based on Global Initiative for Chronic Obstructive Lung Disease [GOLD] definition).
- Show 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%).
- Have been on 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
- Have a documented history of at least 2 moderate or severe ECOPD within the last 12 months prior to Screening.
You may not qualify to participate if you:
- Have any significant pulmonary disease other than COPD.
- Have a requirement for continuous chronic treatment with oxygen at >4.0 liters / minute by nasal cannula or equivalent.
- Have hypoxemia with a resting SpO2 <88% while breathing ambient air (or on the participant’s usual level of oxygen supplementation).
- Have any clinically significant cardiovascular disease, acute and/or severe left heart failure, or heart failure partial ejection fraction, and/or cor pulmonale.
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.
