Back to resultsLYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
Primary Purpose
Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LYR-210
Sham comparator
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Sinusitis
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of CS.
- Two trials of medical treatments for CS in the past.
- Minimum CS symptom score.
- Ability to tolerate topical anesthesia.
- Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
- Agrees to comply with all study requirements.
Exclusion Criteria:
- Have undergone previous sinus surgery.
- Pregnant or breast feeding.
- Known history of hypersensitivity or intolerance to corticosteroids.
- History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
- Known history of hypothalamic pituitary adrenal axial dysfunction or having a morning serum cortisol level at screening outside of the normal range.
- Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
- Past or present functional vision in only one eye.
- Has cataracts
- Past, present, or planned organ transplant or chemotherapy with immunosuppression.
- Currently participating in an investigational drug or device study
Sites / Locations
- Royal Brisbane and Woman's Hospital
- Monash Health
- The ENT Centre
- Westmead Hospital
- University Hospital for Otorhinolaryngology, Medical University of Graz
- Fakultní nemocnice Plzeň
- Fakultni Nemocnice Hradec Kralove Klinika otorinolaryngologie a chirurgie hlavy a krku
- Fakultni Nemocnice Brno OR
- St Anne's Faculty Hospital
- Southern Clinical Trials Waitemata
- Southern Clinical Trials Ltd
- Clinical Trials New Zealand
- Middlemore Clinical Trials
- P3 Research Tauranga
- P3 Research Wellington
- Wellington Hospital
- Provita Sp. z o.o. Centrum Medyczne Angelius Provita
- Centrum Medyczne All-Med
- Centrum Medyczne Plejady
- Centrum Medyczne PROMED
- Centrum Zdrowia MDM
- Vistamed Sp. z o.o.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
LYR-210 (Low Dose)
LYR-210 (High Dose)
Sham Procedure
Arm Description
In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus
In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus
In-office bilateral sham procedure
Outcomes
Primary Outcome Measures
Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4
Participants score their CS symptoms on a 4-point scale as follows: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom present but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The scores are summed and averaged over the proceeding 7 days; higher scores indicate higher severity of symptoms of CS.
Secondary Outcome Measures
Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24
Participants score the severity of their symptoms and social/emotional consequences of CS on a 6-point scale: 0 = no problem, 1 = very mild problem, 2 = mild or slight problem, 3 = moderate problem, 4 = severe problem, 5 = problem as bad as it can be. The scores are summed in the range of 0-110; higher scores indicate higher severity of symptoms or social/emotional consequences of CS.
CFBL in Chronic Sinusitis Symptom Scores at Week 24
Participants score their CS symptoms on a 4-point scale as follows: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom present but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The scores are summed and averaged over the proceeding 7 days; higher scores indicate higher severity of symptoms of CS.
Participants With Improved Bilateral Zinreich Score at Week 24
Each sinus is assigned a score based on the percentage of opacification as follows: 0 = 0%, 1 = 1% to 25%, 2 = 26% to 50%, 3 = 51% to 75%, 4 = 76 % to 99%, 5 = 100% or completely occluded. Each sinus pair has a bilateral score in the range of 0 to 10. Higher scores indicate higher severity of sinus opacification. Responder is defined as a participant with at least a 1-point decrease in the imaging score at Week 24 compared with baseline.
The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks
To evaluate the safety and tolerability of LYR-210
Plasma Drug Concentrations of MF at Week 4
To evaluate the pharmacokinetics of LYR-210
Plasma Drug Concentrations of MF at Week 12
To evaluate the pharmacokinetics of LYR-210
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04041609
Brief Title
LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
Official Title
A Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects With Chronic Sinusitis (LANTERN Study)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 9, 2019 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
February 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lyra Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects with Chronic Sinusitis.
Detailed Description
LYR-210 is a drug depot, which contains the anti-inflammatory medication mometasone furoate (MF) pre-loaded in a single use applicator. LYR-210 is intended to be placed bilaterally into the sino-nasal passages by an otolaryngologist. Once in place, each LYR-210 drug depot is designed to gradually deliver sustained topical doses of MF to the inflamed mucosal sinus tissue over 24 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LYR-210 (Low Dose)
Arm Type
Experimental
Arm Description
In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus
Arm Title
LYR-210 (High Dose)
Arm Type
Experimental
Arm Description
In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus
Arm Title
Sham Procedure
Arm Type
Sham Comparator
Arm Description
In-office bilateral sham procedure
Intervention Type
Drug
Intervention Name(s)
LYR-210
Intervention Description
A single administration of LYR-210 depot
Intervention Type
Other
Intervention Name(s)
Sham comparator
Intervention Description
Sham comparator
Primary Outcome Measure Information:
Title
Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4
Description
Participants score their CS symptoms on a 4-point scale as follows: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom present but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The scores are summed and averaged over the proceeding 7 days; higher scores indicate higher severity of symptoms of CS.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24
Description
Participants score the severity of their symptoms and social/emotional consequences of CS on a 6-point scale: 0 = no problem, 1 = very mild problem, 2 = mild or slight problem, 3 = moderate problem, 4 = severe problem, 5 = problem as bad as it can be. The scores are summed in the range of 0-110; higher scores indicate higher severity of symptoms or social/emotional consequences of CS.
Time Frame
24 weeks
Title
CFBL in Chronic Sinusitis Symptom Scores at Week 24
Description
Participants score their CS symptoms on a 4-point scale as follows: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom present but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The scores are summed and averaged over the proceeding 7 days; higher scores indicate higher severity of symptoms of CS.
Time Frame
Week 24
Title
Participants With Improved Bilateral Zinreich Score at Week 24
Description
Each sinus is assigned a score based on the percentage of opacification as follows: 0 = 0%, 1 = 1% to 25%, 2 = 26% to 50%, 3 = 51% to 75%, 4 = 76 % to 99%, 5 = 100% or completely occluded. Each sinus pair has a bilateral score in the range of 0 to 10. Higher scores indicate higher severity of sinus opacification. Responder is defined as a participant with at least a 1-point decrease in the imaging score at Week 24 compared with baseline.
Time Frame
Week 24
Title
The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks
Description
To evaluate the safety and tolerability of LYR-210
Time Frame
24 weeks
Title
Plasma Drug Concentrations of MF at Week 4
Description
To evaluate the pharmacokinetics of LYR-210
Time Frame
4 Weeks
Title
Plasma Drug Concentrations of MF at Week 12
Description
To evaluate the pharmacokinetics of LYR-210
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of CS.
Two trials of medical treatments for CS in the past.
Minimum CS symptom score.
Ability to tolerate topical anesthesia.
Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
Agrees to comply with all study requirements.
Exclusion Criteria:
Have undergone previous sinus surgery.
Pregnant or breast feeding.
Known history of hypersensitivity or intolerance to corticosteroids.
History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
Known history of hypothalamic pituitary adrenal axial dysfunction or having a morning serum cortisol level at screening outside of the normal range.
Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
Past or present functional vision in only one eye.
Has cataracts
Past, present, or planned organ transplant or chemotherapy with immunosuppression.
Currently participating in an investigational drug or device study
Facility Information:
Facility Name
Royal Brisbane and Woman's Hospital
City
Brisbane
Country
Australia
Facility Name
Monash Health
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Facility Name
The ENT Centre
City
Hornsby
ZIP/Postal Code
2077
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
University Hospital for Otorhinolaryngology, Medical University of Graz
City
Wien
Country
Austria
Facility Name
Fakultní nemocnice Plzeň
City
Plzen
State/Province
Czech Republic
ZIP/Postal Code
305 99
Country
Czechia
Facility Name
Fakultni Nemocnice Hradec Kralove Klinika otorinolaryngologie a chirurgie hlavy a krku
City
Hradec Králové
State/Province
Prague
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni Nemocnice Brno OR
City
Brno
Country
Czechia
Facility Name
St Anne's Faculty Hospital
City
Brno
Country
Czechia
Facility Name
Southern Clinical Trials Waitemata
City
Auckland
ZIP/Postal Code
0626
Country
New Zealand
Facility Name
Southern Clinical Trials Ltd
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
Clinical Trials New Zealand
City
Hamilton
ZIP/Postal Code
3206
Country
New Zealand
Facility Name
Middlemore Clinical Trials
City
Papatoetoe
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
P3 Research Tauranga
City
Tauranga
ZIP/Postal Code
BOP 3110
Country
New Zealand
Facility Name
P3 Research Wellington
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Provita Sp. z o.o. Centrum Medyczne Angelius Provita
City
Katowice
Country
Poland
Facility Name
Centrum Medyczne All-Med
City
Kraków
Country
Poland
Facility Name
Centrum Medyczne Plejady
City
Kraków
Country
Poland
Facility Name
Centrum Medyczne PROMED
City
Kraków
Country
Poland
Facility Name
Centrum Zdrowia MDM
City
Warszawa
Country
Poland
Facility Name
Vistamed Sp. z o.o.
City
Wrocław
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
All Individual Participant Data (IPD) that underlie results in a publication may be available to other researchers.
Citations:
PubMed Identifier
34534410
Citation
Cervin A, Rimmer J, Wrobel A, Abelak Y, Brayton L, Kuang Y. Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study. Int Forum Allergy Rhinol. 2022 Feb;12(2):147-159. doi: 10.1002/alr.22883. Epub 2021 Sep 17.
Results Reference
background
Learn more about this trial
LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
We'll reach out to this number within 24 hrs