LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)

Chronic Sinusitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04041609
• Other study ID #: LYR-210-2018-002
• Secondary ID: 2018-004621-89
• Status: Completed
• Phase: Phase 2
• Start date: May 9, 2019
• Est. completion date: February 4, 2021

Study information

• Verified date: May 2023
• Source: Lyra Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 4, 2021
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Rhinosinusitis (Diagnosis)
• Chronic Sinusitis
• Sinusitis

Intervention

Drug:
• LYR-210
A single administration of LYR-210 depot

Other:
• Sham comparator
Sham comparator

Locations

Country	Name	City	State
Australia	Royal Brisbane and Woman's Hospital	Brisbane
Australia	Monash Health	Clayton
Australia	The ENT Centre	Hornsby
Australia	Westmead Hospital	Westmead
Austria	University Hospital for Otorhinolaryngology, Medical University of Graz	Wien
Czechia	Fakultni Nemocnice Brno OR	Brno
Czechia	St Anne's Faculty Hospital	Brno
Czechia	Fakultni Nemocnice Hradec Kralove Klinika otorinolaryngologie a chirurgie hlavy a krku	Hradec Králové	Prague
Czechia	Fakultní nemocnice Plzen	Plzen	Czech Republic
New Zealand	Southern Clinical Trials Waitemata	Auckland
New Zealand	Southern Clinical Trials Ltd	Christchurch
New Zealand	Clinical Trials New Zealand	Hamilton
New Zealand	Middlemore Clinical Trials	Papatoetoe
New Zealand	P3 Research Tauranga	Tauranga
New Zealand	P3 Research Wellington	Wellington
New Zealand	Wellington Hospital	Wellington
Poland	Provita Sp. z o.o. Centrum Medyczne Angelius Provita	Katowice
Poland	Centrum Medyczne All-Med	Kraków
Poland	Centrum Medyczne Plejady	Kraków
Poland	Centrum Medyczne PROMED	Kraków
Poland	Centrum Zdrowia MDM	Warszawa
Poland	Vistamed Sp. z o.o.	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
Lyra Therapeutics

Countries where clinical trial is conducted

Australia,  Austria,  Czechia,  New Zealand,  Poland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 4
Secondary	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.	24 weeks
Secondary	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.	Week 24
Secondary	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.	Week 24
Secondary	The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks	To evaluate the safety and tolerability of LYR-210	24 weeks
Secondary	Plasma Drug Concentrations of MF at Week 4	To evaluate the pharmacokinetics of LYR-210	4 Weeks
Secondary	Plasma Drug Concentrations of MF at Week 12	To evaluate the pharmacokinetics of LYR-210	12 weeks