Chronic Rhinosinusitis (CRS) in Adults
Conditions
Brief summary
The primary endpoint is the change from baseline (CFBL) in the 7-day average composite score of the 3 cardinal symptoms (3CS) of nasal blockage/obstruction/congestion, facial pain/pressure, and anterior/posterior nasal discharge at Week 24 in participant without nasal polyps.
Detailed description
1.CFBL in the 7-day average composite score of 3CS at Week 24, 2.CFBL in the 7-day average CS score of nasal blockage/obstruction/congestion at Week 24, 3.CFBL in the 7-day average CS score of anterior/posterior nasal discharge at Week 24, 4.CFBL in the 7-day average CS score of facial pain/pressure at Week 24, 5.CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) total score at Week 24, 6.Rescue treatment through Week 24, 7. CFBL in the percent opacification of the bilateral anterior and posterior ethmoids at Week 20, as determined by 3-D volumetric CT analysis.
Interventions
DRUGDEXAMETHASONE
DRUGLYR-210 System
Sponsors
Lyra Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change from baseline (CFBL) in the 7-day average composite score of the 3 cardinal symptoms (3CS) of nasal blockage/obstruction/congestion, facial pain/pressure, and anterior/posterior nasal discharge at Week 24 in participant without nasal polyps. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.CFBL in the 7-day average composite score of 3CS at Week 24, 2.CFBL in the 7-day average CS score of nasal blockage/obstruction/congestion at Week 24, 3.CFBL in the 7-day average CS score of anterior/posterior nasal discharge at Week 24, 4.CFBL in the 7-day average CS score of facial pain/pressure at Week 24, 5.CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) total score at Week 24, 6.Rescue treatment through Week 24, 7. CFBL in the percent opacification of the bilateral anterior and posterior ethmoids at Week 20, as determined by 3-D volumetric CT analysis. | — |
Countries
Belgium, Bulgaria, Germany, Hungary, Poland
Outcome results
None listed