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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517866-40-00
Acronym
C4531029
Enrollment
90
Registered
2025-08-26
Start date
2025-09-29
Completion date
Unknown
Last updated
2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate-to-severe Asthma

Brief summary

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.

Detailed description

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, FVC , % predicted FVC, FEV1/FVC ratio) at all other time points., CFB in FEV1 as a % of pre-BD result., 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.

Interventions

DRUGPF-07275315 Placebo

Sponsors

Pfizer Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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, FVC , % predicted FVC, FEV1/FVC ratio) at all other time points., CFB in FEV1 as a % of pre-BD result., 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.

Countries

Belgium, Bulgaria, Czechia, Hungary, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026