C4531031 - 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)

MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Phase 2: Change from baseline (CFB) in pre-bronchodilator (BD) forced expiratory volume in one second (FEV1) at Week 24 compared to placebo., Phase 3: Annualized rate of moderate or severe ECOPD.

Phase 2 • Annualized rate of moderate or severe ECOPD. • CFB in pre-BD FEV1 at all time points in SoA during treatment period up to Week 24. • CFB in trough, pre- and post-BD FEV1 at each time point in schedule of activities (SoA) during treatment period up to Week 24., Phase 2 • CFB in trough, pre- and post-BD forced vital capacity (FVC) and FEV1/FVC ratio, % predicted FEV1, % predicted FVC at each time point in SoA during treatment period up to Week 24. • CFB in trough FEV1 responsiveness to BD, at each timepoint in SoA during treatment period up to Week 24., Phase 2: • Incidence and severity of treatment-emergent adverse events (TEAE) throughout Phase 2 part of the study. • Incidence of treatment-emergent serious adverse events (SAE) and TEAEs leading to discontinuation. • Incidence of clinical abnormalities and CFB in clinical laboratory values, electrocardiogram (ECG) measurements, and vital signs., Phase 3 Key Secondary Endpoints • CFB in pre- and post-BD FEV1 at Week 12 and Week 52. • Percentage of participants with ≥4 points improvement from baseline in Saint Georges Respiratory Questionnaire (SGRQ) score at Week 52. • Percentage of participants with ≥2 points improvement from baseline in COPD assessment test (CAT) total score at Week 52., Phase 3 Key Secondary Endpoints • Percentage of participants with ≥2 points improvement from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score at Week 52. • Annualized rate of severe ECOPD. • Annualized rate of exacerbations requiring emergency department visit and/or hospitalization.

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