Chronic Sinusitis Clinical Trial
Official title:
ENLIGHTEN 2: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults
Multicenter, phase III, randomized, blinded, controlled, parallel group.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Lyra Therapeutics |
United States, Belgium, Bulgaria, Germany, Hungary, Poland,
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 |
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 |