Moderate to Severe Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
Brief summary
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.
Interventions
DRUGPF-07275315 dose 1
SC injection dose 1
DRUGPF-07275315-dose 2
SC injection dose 2
DRUGPlacebo
SC injection matched
DRUGPF-07275315-dose 3
SC injection dose 3
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All dosing syringes will be masked and an unblinded administrator will administer the study intervention.
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 2 part: Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 24 | Baseline to Week 24 | FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 is obtained from spirometry. |
| Phase 3 part: Annualized rate of moderate or severe ECOPD | Baseline to Week 52 | Exacerbation of Chronic Obstructive Pulmonary Disease (ECOPD) are sudden worsening of respiratory symptoms that significantly worsen lung function and quality of life. |
Secondary
| Measure | Time frame |
|---|---|
| Phase 2: Annualized rate of moderate or severe ECOPD. | Baseline to Week 24 |
| Phase 2: Change from baseline in pre-BD FEV1 up to Week 24. | Baseline to Week 24 |
| Phase 2: Change from baseline in trough, pre- and post-BD FEV1 up to Week 24 | Baseline to Week 24 |
| Phase 2: Change from baseline in trough, pre- and post-BD FVC and FEV1/FVC ratio, % predicted FEV1, % predicted FVC up to Week 24. | Baseline to Week 24 |
| Phase 2: Change from baseline in trough FEV1 responsiveness to BD up to Week 24. | Baseline to Week 24 |
| Phase 2: Incidence and severity of TEAEs throughout Phase 2 part of the study. | Baseline to Week 24 |
| Phase 2: Incidence of treatment-emergent adverse events and serious adverse events leading to discontinuation. | Baseline to Week 24 |
| Phase 2: Incidence of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs. | Baseline to Week 24 |
| Phase 3: change from baseline in pre- and post-BD FEV1 at Week 12 and Week 52. | Baseline to Week 52 |
| Phase 3: Percentage of participants with ≥4 points improvement from baseline in Saint George's Respiratory Questionnaire (SGRQ) score at Week 52. | Baseline to Week 52 |
| Phase 3: Percentage of participants with ≥2 points improvement from baseline in the COPD Assessment Test (CAT) total score at Week 52. | Baseline to Week 52 |
| Phase 3: Percentage of participants with ≥2 points improvement from baseline in E-RS:COPD total score at Week 52. | Baseline to Week 52 |
| Phase 3: Annualized rate of severe ECOPD. | Baseline to Week 52 |
| Phase 2: Change from baseline of clinical abnormalities in clinical laboratory values, ECG measurements, and vital signs. | Baseline to Week 24 |
| Phase 3: Annualized rate of exacerbations requiring emergency department visit and/or hospitalization. | Baseline to Week 52 |
Countries
Argentina, Canada, China, Czechia, Hungary, India, Japan, South Korea, Taiwan, United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed