Respiratory tract diseases
Conditions
Brief summary
Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring)
Detailed description
Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT), Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT, Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT), Change from baseline to Week 24 in Reactance area (AX) measured by FOT, Incidence of Treatment-Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) including potentially clinically significant abnormalities
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT), Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT, Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT), Change from baseline to Week 24 in Reactance area (AX) measured by FOT, Incidence of Treatment-Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) including potentially clinically significant abnormalities | — |
Countries
Austria, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden