Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)

In brief

Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.

Key facts

Study ID

NCT05219968

Run by

Lyra Therapeutics

People needed

196

Starts

2022-01-27

Expected to finish

2024-09-16

Last updated by the study team

2025-05-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18
• Diagnosed as having CRS
• Undergone at least 2 trials of medical treatments in the past
• Mean 3 cardinal symptom (3CS) score
• Bilateral ethmoid disease confirmed on CT
• Has been informed of the nature of the study and provided written informed consent
• Agrees to comply with all study requirements
• If on a waiting list for sinonasal surgery, willing to be removed from list or have surgery date cancelled for the duration of the study.

You may not qualify if…

• Inability to tolerate topical anesthesia or endoscopic procedure
• Previous nasal surgery
• Presence of nasal polyp grade 2 or higher
• Seasonal allergic rhinitis
• Perennial rhinitis with symptoms that are well controlled by regular use of intranasal corticosteroids
• Severe asthma
• History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis
• Obstruction preventing proper placement and retention of LYR-210 as seen on endoscopy
• Anatomic variation that, in the opinion of the investigator, would adversely impact placement of LYR-210 as seen on CT
• Known history of hypersensitivity or intolerance to corticosteroids
• Known history of hypothalamic pituitary adrenal axial dysfunction
• Previous pituitary or adrenal surgery
• Dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
• Past or present acute or chronic intracranial or orbital complications of CRS
• History or diagnosis (in either eye) of glaucoma or ocular hypertension
• Past or present functional vision in only 1 eye
• Past, present, or planned organ transplant or chemotherapy with immunosuppression
• Currently positive for COVID-19 or residual sinonasal symptoms from a previous COVID-19 infection
• Pregnant or breast feeding. Females of child-bearing potential must test negative for pregnancy at the time of screening
• Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments
• Currently participating in an investigational drug or device study
• Determined by the investigator as not suitable to be enrolled

Where it is running

• Lyra Investigational Site — Elblag, Poland
• 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
• Lyra Investigational Site — Torrance, California, United States
• Lyra Investigational Site — Boca Raton, Florida, United States
• Lyra Investigational Site — Boynton Beach, Florida, United States
• Lyra Investigational Site — Plantation, Florida, United States
• Lyra Investigational Site — Port Saint Lucie, Florida, United States
• Lyra Investigational Site — Chicago, Illinois, United States
• Lyra Investigational Site — Louisville, Kentucky, United States
• Lyra Investigational Site — Baltimore, Maryland, United States
• Lyra Investigational Site — New Hyde Park, New York, United States
• Lyra Investigational Site — New York, New York, United States
• Lyra Investigational Site — New York, New York, United States
• Lyra Investigational Site — New York, New York, United States
• Lyra Investigational Site — Winston-Salem, North Carolina, United States
• Lyra Investigational Site — Charleston, South Carolina, United States
• Lyra Investigational Site — Spartanburg, South Carolina, United States
• Lyra Investigational Site — Nashville, Tennessee, United States
• Lyra Investigational Site — Fort Worth, Texas, United States
• Lyra Investigational Site — Houston, Texas, United States
• Lyra Investigational Site — Mansfield, Texas, United States
• Lyra Investigational Site — Bydgoszcz, Poland

Full record on ClinicalTrials.gov

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