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

NCT ID: NCT04041609

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-09
• Study Completion Date: 2021-02-04

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.

Conditions

Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LYR-210 (Low Dose)

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus

Group Type: EXPERIMENTAL

LYR-210

Intervention Type: DRUG

A single administration of LYR-210 depot

LYR-210 (High Dose)

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus

Group Type: EXPERIMENTAL

LYR-210

Intervention Type: DRUG

A single administration of LYR-210 depot

Sham Procedure

In-office bilateral sham procedure

Group Type: SHAM_COMPARATOR

Sham comparator

Intervention Type: OTHER

Sham comparator

Interventions

LYR-210

A single administration of LYR-210 depot

Intervention Type: DRUG

Sham comparator

Sham comparator

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lyra Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Brisbane and Woman's Hospital

Brisbane, , Australia

Monash Health

Clayton, , Australia

The ENT Centre

Hornsby, , Australia

Westmead Hospital

Westmead, , Australia

University Hospital for Otorhinolaryngology, Medical University of Graz

Vienna, , Austria

Fakultní nemocnice Plzeň

Pilsen, Czech Republic, Czechia

Fakultni Nemocnice Hradec Kralove Klinika otorinolaryngologie a chirurgie hlavy a krku

Hradec Králové, Prague, Czechia

Fakultni Nemocnice Brno OR

Brno, , Czechia

St Anne's Faculty Hospital

Brno, , Czechia

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, , New Zealand

Provita Sp. z o.o. Centrum Medyczne Angelius Provita

Katowice, , Poland

Centrum Medyczne All-Med

Krakow, , Poland

Centrum Medyczne Plejady

Krakow, , Poland

Centrum Medyczne PROMED

Krakow, , Poland

Centrum Zdrowia MDM

Warsaw, , Poland

Vistamed Sp. z o.o.

Wroclaw, , Poland

Countries

Australia; Austria; Czechia; New Zealand; Poland

References

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.

Reference Type: BACKGROUND

PMID: 34534410 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-004621-89

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LYR-210-2018-002

Identifier Type: -

Identifier Source: org_study_id