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

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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)
• Intervention / Treatment: Drug: LYR-210; Other: Sham comparator

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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Brisbane, Australia
    • Royal Brisbane and Woman's Hospital
  • Clayton, Australia, 3168
    • Monash Health
  • Hornsby, Australia, 2077
    • The ENT Centre
  • Westmead, Australia, 2145
    • Westmead Hospital
• Austria
  • Wien, Austria
    • University Hospital for Otorhinolaryngology, Medical University of Graz
• Czechia
  • Brno, Czechia
    • Fakultni Nemocnice Brno OR
  • Brno, Czechia
    • St Anne's Faculty Hospital
  • Czech Republic
    • Plzen, Czech Republic, Czechia, 305 99
      • Fakultni nemocnice Plzen
  • Prague
    • Hradec Králové, Prague, Czechia, 500 05
      • Fakultni Nemocnice Hradec Kralove Klinika otorinolaryngologie a chirurgie hlavy a krku
• New Zealand
  • Auckland, New Zealand, 0626
    • Southern Clinical Trials Waitemata
  • Christchurch, New Zealand, 8013
    • Southern Clinical Trials Ltd
  • Hamilton, New Zealand, 3206
    • Clinical Trials New Zealand
  • Papatoetoe, New Zealand, 2025
    • Middlemore Clinical Trials
  • Tauranga, New Zealand, BOP 3110
    • P3 Research Tauranga
  • Wellington, New Zealand, 6021
    • Wellington Hospital
  • Wellington, New Zealand, 6021
    • P3 Research Wellington
• Poland
  • Katowice, Poland
    • Provita Sp. z o.o. Centrum Medyczne Angelius Provita
  • Kraków, Poland
    • Centrum Medyczne All-Med
  • Kraków, Poland
    • Centrum Medyczne PLEJADY
  • Kraków, Poland
    • Centrum Medyczne Promed
  • Warszawa, Poland
    • Centrum Zdrowia MDM
  • Wrocław, Poland
    • Vistamed Sp. z o.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LYR-210 (Low Dose); In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus	Drug: LYR-210; A single administration of LYR-210 depot
Experimental: LYR-210 (High Dose); In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus	Drug: LYR-210; A single administration of LYR-210 depot
Sham Comparator: Sham Procedure; In-office bilateral sham procedure	Other: Sham comparator; Sham comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Plasma Drug Concentrations of MF at Week 4	To evaluate the pharmacokinetics of LYR-210	4 Weeks
Plasma Drug Concentrations of MF at Week 12	To evaluate the pharmacokinetics of LYR-210	12 weeks

Collaborators and Investigators

• Sponsor: Lyra Therapeutics

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Actual): March 25, 2020
• Study Completion (Actual): February 4, 2021

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Chronic Disease
• Other Study ID Numbers: LYR-210-2018-002; 2018-004621-89 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: All Individual Participant Data (IPD) that underlie results in a publication may be available to other researchers.

Drug and device information, study documents

• 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