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

NCT05219968 | Completed Phase 3 Results FDA Drug

• 1 other identifier: LYR-210-2021-004
• Study Type: interventional
• Target: 196
• Locations: 5 countries
• Sites: 55

Brief Summary

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

Conditions

Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• 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.

  24 Weeks

Secondary Outcomes (4)

• CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24.

  Week 24

• CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24

  Week 24

• CFBL in the 3-D Volumetric CT Score at Week 20

  Week 20

• Participants With Rescue Treatments for CRS Through Week 24

  Week 24

Study Arms (2)

LYR-210

EXPERIMENTAL

Single administration of LYR-210 drug matrix (7500 μg)

Drug: LYR-210; Other: Background Therapy

Sham procedure control

SHAM COMPARATOR

Single mock administration procedure

Drug: Sham procedure control; Other: Background Therapy

Interventions

LYR-210 DRUG

LYR-210 drug matrix (mometasone furoate)

LYR-210

Sham procedure control DRUG

Sham procedure control

Sham procedure control

Background Therapy OTHER

Daily Saline Irrigation

LYR-210; Sham procedure control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Lyra Therapeutics: lead

Study Sites (55)

Lyra Investigational Site

Birmingham, Alabama, 35294-0012, United States

Location

Lyra Investigational Site

Escondido, California, 92025, United States

Location

Lyra Investigational Site

La Mesa, California, 91942, United States

Location

Lyra Investigational Site

Sacramento, California, 95661, United States

Location

Lyra Investigational Site

Torrance, California, 90503, United States

Location

Lyra Investigational Site

Boca Raton, Florida, 33487-5713, United States

Location

Lyra Investigational Site

Boynton Beach, Florida, 33426, United States

Location

Lyra Investigational Site

Plantation, Florida, 33324, United States

Location

Lyra Investigational Site

Port Saint Lucie, Florida, 34952, United States

Location

Lyra Investigational Site

Chicago, Illinois, 60657, United States

Location

Lyra Investigational Site

Louisville, Kentucky, 40220, United States

Location

Lyra Investigational Site

Baltimore, Maryland, 21287, United States

Location

Lyra Investigational Site

New Hyde Park, New York, 11042, United States

Location

Lyra Investigational Site

New York, New York, 10003, United States

Location

Lyra Investigational Site

New York, New York, 10016, United States

Location

Lyra Investigational Site

New York, New York, 10029, United States

Location

Lyra Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Lyra Investigational Site

Charleston, South Carolina, 29425, United States

Location

Lyra Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

Lyra Investigational Site

Nashville, Tennessee, 37232-8605, United States

Location

Lyra Investigational Site

Fort Worth, Texas, 76109, United States

Location

Lyra Investigational Site

Houston, Texas, 77030, United States

Location

Lyra Investigational Site

Mansfield, Texas, 76063, United States

Location

Lyra Investigational Site

San Antonio, Texas, 78258, United States

Location

Lyra Investigational Site

South Ogden, Utah, 84405, United States

Location

Lyra Investigational Site

Norfolk, Virginia, 23507, United States

Location

Lyra Investigational Site

Graz, A-8036, Austria

Location

Lyra Investigational Site

Klagenfurt, 9020, Austria

Location

Lyra Investigational Site

Linz, 4010, Austria

Location

Lyra Investigational Site

Vienna, 1090, Austria

Location

Lyra Investigational Site

Brno, 656 91, Czechia

Location

Lyra Investigational Site

Hradec Králové, 500 05, Czechia

Location

Lyra Investigational Site

Motol, 150 06, Czechia

Location

Lyra Investigational Site

Olomouc, 77900, Czechia

Location

Lyra Investigational Site

Prague, 140 59, Czechia

Location

Lyra Investigational Site

Bydgoszcz, 85-047, Poland

Location

Lyra Investigational Site

Bydgoszcz, 85-605, Poland

Location

Lyra Investigational Site

Elblag, 82-300, Poland

Location

Lyra Investigational Site

Katowice, 40-611, Poland

Location

Lyra Investigational Site

Krakow, 30-033, Poland

Location

Lyra Investigational Site

Krakow, 31-411, Poland

Location

Lyra Investigational Site

Krosno, 38-400, Poland

Location

Lyra Investigational Site

Lublin, 20-362, Poland

Location

Lyra Investigational Site

Nadarzyn, 05-830, Poland

Location

Lyra Investigational Site

Warsaw, 00-635, Poland

Location

Lyra Investigational Site

Warsaw, 04-141, Poland

Location

Lyra Investigational Site

Wroclaw, 53-149, Poland

Location

Lyra Investigational Site

Barcelona, 08003, Spain

Location

Lyra Investigational Site

Barcelona, 08022, Spain

Location

Lyra Investigational Site

Bilbao, 48013, Spain

Location

Lyra Investigational Site

Cadiz, 11407, Spain

Location

Lyra Investigational Site

Granada, 18014, Spain

Location

Lyra Investigational Site

Madrid, 28034, Spain

Location

Lyra Investigational Site

Navarro, 31008, Spain

Location

Lyra Investigational Site

Santander, 39008, Spain

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Clinical Affairs
• Organization: Lyra Therapeutics

lyraclinical@lyratx.com

617-393-4600

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: January 27, 2022
• Primary Completion: March 4, 2024
• Study Completion: September 16, 2024
• Last Updated: May 2, 2025
• Results First Posted: May 2, 2025

Record last verified: 2025-04

Locations

US (26); AU (4); ES (8); CZ (5); PL (12)