Chronic Rhinosinusitis without Nasal Polyps (CRSsNP)
Conditions
Brief summary
Change from Baseline to the 28-day average of daily Sinus Total Symptom Score (sTSS)a at Week 24
Detailed description
Change from Baseline in percentage of sinus (maxillary and ethmoid) opacification as measured by volumetry at Week 24, Change from Baseline in modified Lund-MacKay (LMK) CT score at Week 24, Participant status indicator for requiring rescue (antibiotics, SCS, and/or nasal surgery) due to worsening of any CRS symptom, Change from Baseline to the 28-day average of daily Nasal Congestion Scores (NCS) at Weeks 24, Change from Baseline to the 28-day average of daily Peak Nasal Inspiratory Flow (PNIF) at Week 24, Change from Baseline in Sino-Nasal Outcome Test (SNOT-22) at Week 24, Brensocatib plasma concentration, Adverse events (AEs) over 24 weeks of treatment, Clinical laboratory test results, vital signs, and electrocardiograms (ECGs) over 24 weeks of treatment
Interventions
Sponsors
Insmed Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to the 28-day average of daily Sinus Total Symptom Score (sTSS)a at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in percentage of sinus (maxillary and ethmoid) opacification as measured by volumetry at Week 24, Change from Baseline in modified Lund-MacKay (LMK) CT score at Week 24, Participant status indicator for requiring rescue (antibiotics, SCS, and/or nasal surgery) due to worsening of any CRS symptom, Change from Baseline to the 28-day average of daily Nasal Congestion Scores (NCS) at Weeks 24, Change from Baseline to the 28-day average of daily Peak Nasal Inspiratory Flow (PNIF) at Week 24, Change from Baseline in Sino-Nasal Outcome Test (SNOT-22) at Week 24, Brensocatib plasma concentration, Adverse events (AEs) over 24 weeks of treatment, Clinical laboratory test results, vital signs, and electrocardiograms (ECGs) over 24 weeks of treatment | — |
Countries
Belgium, Bulgaria, Czechia, Denmark, France, Germany, Hungary, Italy, Poland, Portugal, Spain
Outcome results
None listed