C4531029:A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Dose-Ranging Study to Investigate the Efficacy and Safety of PF-07275315 in Adult Participants with Inadequately Controlled Moderate-to-Severe Asthma

Condition studied

Moderate-to-severe Asthma

Eligibility

Primary endpoint

Change from baseline (CFB) in pre-bronchodilator forced expiratory volume (in mL) in one second (FEV1) at Week 12., Incidence of treatment-emergent adverse events (TEAEs, all causality and treatment-related)., Incidence of treatment-emergent serious adverse events (SAEs)., Discontinuations due to TEAEs or SAEs., Clinically significant, treatment-related abnormal laboratory values, vital signs or electrocardiograms.

Endpoint detail

Key Secondary: • CFB in pre-bronchodilator % predicted FEV1, at Week 12., Other Secondary: CFB in pre-bronchodilator lung function parameters (ie, FEV1 *, % predicted FEV1*, Forced vital capacity [FVC], % predicted FVC, FEV1/FVC ratio) at all other time points., CFB in post-bronchodilator lung function parameters (ie, FEV1 , % predicted FEV1 (all time points except Week 12), FVC , % predicted FVC, FEV1/FVC ratio) at all other time points., Percentage CFB in pre-BD FEV1 at all time points., CFB in pre-bronchodilator FEV1 at Week 12., CFB in pre-bronchodilator FEV1 at Week 12., CFB in asthma control questionnaire (5-question version [ACQ-5]) total score at Week 12., CFB in asthma quality of life questionnaire with standardized activities (AQLQ) self-administered global score at Week 12., CFB in pre- bronchodilator FEV1 at Week 12.