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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05219968
Other study ID # LYR-210-2021-004
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date January 27, 2022
Est. completion date September 15, 2024

Study information

Verified date September 2023
Source Lyra Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 196
Est. completion date September 15, 2024
Est. primary completion date March 4, 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 - 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. Exclusion Criteria: - 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

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
Austria Lyra Investigational Site Graz
Austria Lyra Investigational Site Klagenfurt am Worthersee
Austria Lyra Investigational Site Linz
Austria Lyra Investigational Site Wien
Czechia Lyra Investigational Site Brno
Czechia Lyra Investigational Site Hradec Králové
Czechia Lyra Investigational Site Motol
Czechia Lyra Investigational Site Olomouc
Czechia Lyra Investigational Site Praha
Poland Lyra Investigational Site Bydgoszcz
Poland Lyra Investigational Site Bydgoszcz
Poland Lyra Investigational Site Elblag
Poland Lyra Investigational Site Katowice
Poland Lyra Investigational Site Kraków
Poland Lyra Investigational Site Kraków
Poland Lyra Investigational Site Krosno
Poland Lyra Investigational Site Lublin
Poland Lyra Investigational Site Nadarzyn
Poland Lyra Investigational Site Warszawa
Poland Lyra Investigational Site Warszawa
Poland Lyra Investigational Site Wroclaw
Spain Lyra Investigational Site Barcelona
Spain Lyra Investigational Site Barcelona
Spain Lyra Investigational Site Bilbao
Spain Lyra Investigational Site Cadiz
Spain Lyra Investigational Site Granada
Spain Lyra Investigational Site Madrid
Spain Lyra Investigational Site Navarro
Spain Lyra Investigational Site Santander
United States Lyra Investigational Site Baltimore Maryland
United States Lyra Investigational Site Birmingham Alabama
United States Lyra Investigational Site Boca Raton Florida
United States Lyra Investigational Site Boynton Beach Florida
United States Lyra Investigational Site Charleston South Carolina
United States Lyra Investigational Site Chicago Illinois
United States Lyra Investigational Site Escondido California
United States Lyra Investigational Site Fort Worth Texas
United States Lyra Investigational Site Houston Texas
United States Lyra Investigational Site La Mesa California
United States Lyra Investigational Site Louisville Kentucky
United States Lyra Investigational Site Mansfield Texas
United States Lyra Investigational Site Nashville Tennessee
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 Norfolk Virginia
United States Lyra Investigational Site Plantation Florida
United States Lyra Investigational Site Port Saint Lucie Florida
United States Lyra Investigational Site Sacramento California
United States Lyra Investigational Site San Antonio Texas
United States Lyra Investigational Site South Ogden Utah
United States Lyra Investigational Site Spartanburg South Carolina
United States Lyra Investigational Site Torrance California
United States Lyra Investigational Site Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Lyra Therapeutics

Countries where clinical trial is conducted

United States,  Austria,  Czechia,  Poland,  Spain, 

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 in all participants 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. Week 24
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. Week 24
Secondary 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. Week 20
Secondary Number and percent of participants requiring rescue treatment through Week 24 This endpoint will be descriptively summarized. Week 24
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