Moderate-to-severe Asthma
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time 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
| Measure | Time 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