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)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- Pfizer Inc.
- 入组人数
- 1,056
- 试验地点
- 10
研究概览
简要总结
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 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •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] per forced vital capacity [FVC] less than 70 percent and post-bronchodilator FEV1 percent predicted less than 70 percent, but greater than equal to 30 percent).
- •Continuous treatment with standard of care triple therapy of LABA + LAMA + ICS for greater than equal to 6 months prior to Screening Visit 1 and at a stable dose for greater than equal to 3 months
- •Documented history of at least 2 moderate or severe ECOPD within the last 12 months prior to Screening.
排除标准
- •Significant pulmonary disease other than COPD.
- •Requirement for continuous chronic treatment with oxygen at greater than 4.0 liters per minute by nasal cannula or equivalent.
- •Hypoxemia with a resting SpO2 less than 88 percent while breathing ambient air (or on the participants 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.