Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.
This is a 52-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period followed by a safety extension phase with crossover or continued treatment to evaluate the efficacy and safety of LYR-210 compared with sham control for treatment in adults with CRS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
196
LYR-210 drug matrix (mometasone furoate)
Sham procedure control
Daily Saline Irrigation
Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps.
The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.
Time frame: 24 Weeks
CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24.
The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.
Time frame: Week 24
CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24
The SNOT-22 questionnaire is a 22-item disease-specific quality of life instrument. Each symptom is scored on a 6-point scale where 0 = no problem and 5 = problem as bad as it can be. The total SNOT-22 score is the sum of the 22 items and can range from 0 to 110 with higher scores indicating worse symptoms.
Time frame: Week 24
CFBL in the 3-D Volumetric CT Score at Week 20
The percent opacification of the bilateral anterior and posterior ethmoids will be assessed by 3-D volumetric CT analysis at baseline and Week 20. A negative change from Baseline indicates improvement from Baseline.
Time frame: Week 20
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Lyra Investigational Site
Birmingham, Alabama, United States
Lyra Investigational Site
Escondido, California, United States
Lyra Investigational Site
La Mesa, California, United States
Lyra Investigational Site
Sacramento, California, United States
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Torrance, California, United States
Lyra Investigational Site
Boca Raton, Florida, United States
Lyra Investigational Site
Boynton Beach, Florida, United States
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Plantation, Florida, United States
Lyra Investigational Site
Port Saint Lucie, Florida, United States
Lyra Investigational Site
Chicago, Illinois, United States
...and 45 more locations
Participants With Rescue Treatments for CRS Through Week 24
This endpoint is descriptively summarized per the prespecified plan. This includes participants that used systemic corticosteroid for any reason as well as participants that were recommended/underwent sinonasal surgery.
Time frame: Week 24