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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.


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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

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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
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