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Clinical trial to evaluate the efficacy and safety of LYR-210 for the treatment of chronic rhinosinusitis in adults
CHRONIC RHINOSINUSITIS IS AN INFLAMMATORY (SWELLING) DISORDER OF THE NASAL PASSAGES THAT LASTS MORE THAN 12 WEEKS. THE MAIN SYMPTOMS ARE NASAL OBSTRUCTION OR CONGESTION, FACIAL PRESSURE OR PAIN, NASAL DISCHARGE (MUCUS) AND REDUCED OR LOSS OF SENSE OF SMELL. THE LYR-210 SYSTEM CONSISTS OF A DRUG MATRIX INSERTED INTO A SINGLE-USE APPLICATOR. THE DRUG MATRIX CONTAINS 7500 UG OF MOMETASONE FUROATE (MF) EMBEDDED IN BIORESORBABLE POLYMERS. MOMETASONE FUROATE IS A TOPICAL ANTI-INFLAMMATORY CORTICOSTEROID USED IN NASAL SPRAY FOR CRS, ALLERGIC RHINITIS AND NASAL POLYPS (GROWTH ON THE MUCOSA OF THE NOSE OR SINUSES) AND IN INHALER FOR ASTHMA. THE DRUG MATRIX IS SMALL AND FLEXIBLE AND IS DESIGNED TO FIT INTO THE NASAL CAVITY. IT IS ADMINISTERED INSIDE THE NOSE WITH AN APPLICATOR. THE OBJECTIVE OF THIS STUDY IS TO DETERMINE WHETHER A STUDY PRODUCT, THE LYR-210 DRUG MATRIX, WORKS AND IS SAFE IN PARTICIPANTS WITH CHRONIC RHINOSINUSITIS.
Technical Summary
- ENLIGHTEN 1: PHASE III, RANDOMIZED, BLINDED, CONTROLLED, PARALLEL-ARM, CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF LYR-210 FOR THE TREATMENT OF CHRONIC RHINOSINUSITIS (CRS) IN ADULTS
- Code EudraCT: 2021-005906-83
- Protocol number: LYR-210-2021-004
- Promoter: Lyra Therapeutics
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