Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05295459
Other study ID # LYR-210-2021-005
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 13, 2022
Est. completion date December 15, 2024

Study information

Verified date March 2024
Source Lyra Therapeutics
Contact Lyra Clinical
Phone 617-393-4600
Email lyraclinical@lyratx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Multicenter, phase III, randomized, blinded, controlled, parallel group.


Description:

This is a 24-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period to evaluate the efficacy and safety of LYR-210 compared with sham control for treatment in adults with CRS.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date December 15, 2024
Est. primary completion date December 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Inability to tolerate topical anesthesia - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LYR-210
LYR-210 drug matrix (mometasone furoate)
Sham procedure control
Sham procedure control
Other:
Background therapy
Daily Saline Irrigation

Locations

Country Name City State
Belgium Lyra Investigational Site Brussels
Belgium Lyra Investigation Site Gent
Belgium Lyra Investigational Site Leuven
Bulgaria Lyra Investigational Site Burgas
Bulgaria Lyra Investigational Site Pleven
Bulgaria Lyra Investigational Site Plovdiv
Bulgaria Lyra Investigational Site Sofia
Bulgaria Lyra Investigational Site Varna
Germany Lyra Investigational Site Baden
Germany Lyra Investigational Site Berlin
Germany Lyra Investigational Site Dresden
Germany Lyra Investigational Site Landsberg
Germany Lyra Investigational Site Tuebingen
Hungary Lyra Investigational Site Budapest
Hungary Lyra Investigational Site Budapest
Hungary Lyra Investigational Site Budapest
Hungary Lyra Investigational Site Budapest
Hungary Lyra Investigational Site Budapest
Hungary Lyra Investigational Site Nyíregyháza
Hungary Lyra Investigational Site Pécs
Hungary Lyra Investigational Site Tatabánya
Poland Lyra Investigational Site Bialystok
Poland Lyra Investigational Site Inowroclaw
Poland Lyra Investigational Site Krakow
Poland Lyra Investigational Site Lublin
Poland Lyra Investigational Site Warszawa
Poland Lyra Investigational Site Warszawa
Poland Lyra Investigational Site Wroclaw
United States Lyra Investigational Site Arcadia California
United States Lyra Investigational Site Boca Raton Florida
United States Lyra Investigational Site Boston Massachusetts
United States Lyra Investigational Site Boston Massachusetts
United States Lyra Investigational Site Boynton Beach Florida
United States Lyra Investigational Site Brandon Florida
United States Lyra Investigational Site Chicago Illinois
United States Lyra Investigational Site Chicago Illinois
United States Lyra Investigational Site Cincinnati Ohio
United States Lyra Investigational Site Cleveland Ohio
United States Lyra Investigational Site Colorado Springs Colorado
United States Lyra Investigational Site Columbia Missouri
United States Lyra Investigational Site Fairway Kansas
United States Lyra Investigational Site Houston Texas
United States Lyra Investigational Site Indianapolis Indiana
United States Lyra Investigational Site Lebanon New Hampshire
United States Lyra Investigational Site Los Angeles California
United States Lyra Investigational Site Los Angeles California
United States Lyra Investigational Site Marrero Louisiana
United States Lyra Investigational Site McKinney Texas
United States Lyra Investigational Site New York New York
United States Lyra Investigational Site New York New York
United States Lyra Investigational Site Ogden Utah
United States Lyra Investigational Site Orange California
United States Lyra Investigational Site Orangeburg South Carolina
United States Lyra Investigational Site Plantation Florida
United States Lyra Investigational Site Port Saint Lucie Florida
United States Lyra Investigational Site Richmond Virginia
United States Lyra Investigational Site Rochester New York
United States Lyra Investigational Site Roseville California
United States Lyra Investigational Site Sacramento California
United States Lyra Investigational Site Saint Louis Missouri
United States Lyra Investigational Site San Diego California
United States Lyra Investigational Site Torrance California
United States Lyra Investigational Site Tucson Arizona
United States Lyra Investigational Site Wesley Chapel Florida
United States Lyra Investigational Site White Plains New York
United States Lyra Investigational Site Wilkes-Barre Pennsylvania
United States Lyra Investigational Site Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Lyra Therapeutics

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Germany,  Hungary,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores. 24 Weeks
Secondary CFBL in the 7-day average composite score of 3CS at Week 24. The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores. 24 Weeks
Secondary CFBL in the 7-day average CS score of nasal blockage/obstruction/congestion at Week 24. Nasal blockage/obstruction/congestion is one of the 3 cardinal symptoms. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms. 24 Weeks
Secondary CFBL in the 7-day average CS score of anterior/posterior nasal discharge at Week 24. Anterior/posterior nasal discharge is one of the 3 cardinal symptoms. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms. 24 Weeks
Secondary CFBL in the 7-day average CS score of facial pain/pressure at Week 24. Facial pain/pressure is one of the 3 cardinal symptoms. Each symptom is rated on a 4-point (0-3) scale where 0=absent symptoms and 3=severe symptoms. 24 Weeks
Secondary 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. 24 Weeks
Secondary CFBL in the 3-D volumetric CT score at Week 20. 20 Weeks
Secondary Number and percent of participants requiring rescue treatment through Week 24 24 Weeks
See also
  Status Clinical Trial Phase
Completed NCT02266810 - Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus Phase 3
Completed NCT01706484 - Efficacy and Safety of Two Dosages of a Herbal Medicinal Product (Dry Extract BNO 1016) in Chronic Rhinosinusitis Phase 3
Completed NCT01197612 - Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis Phase 3
Completed NCT04163978 - Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS) Phase 2
Completed NCT04418622 - Evolution of the Endonasal Microbiota in Patients With Chronic Rhinosinusitis
Not yet recruiting NCT06070311 - Wound Healing After Endoscopic Sinus Surgery N/A
Not yet recruiting NCT05454163 - Post-radiotherapy Rhinosinusitis in Children
Withdrawn NCT01185808 - Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps N/A
Completed NCT01700725 - Gulf War Illness Nasal Irrigation Study Phase 2
Withdrawn NCT00671281 - The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery N/A
Completed NCT00447837 - Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis Phase 2
Recruiting NCT04362501 - Efficacy of Dupilumab for Patients With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) Phase 2
Completed NCT05035654 - LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study) Phase 2
Completed NCT02562924 - The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery N/A
Completed NCT01007799 - Vitamin D for Chronic Sinusitis N/A
Completed NCT03358329 - Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE) Phase 3
Withdrawn NCT02981017 - Improvement of Outcomes in Draf III/Endoscopic Modified Lothrop Procedure N/A
Completed NCT04041609 - LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study) Phase 2
Recruiting NCT01854619 - Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis N/A
Completed NCT00924404 - Xylitol Versus Saline in Chronic Sinusitis N/A