Evidence map›Paper›PMID 34534410›Full record

Trial reportInternational forum of allergy & rhinology2022

Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study.

Anders Cervin, Joanne Rimmer, Agnieszka Wrobel, Yogen Abelak, Lindsay Brayton, Yina Kuang

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International forum of allergy & rhinology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04041609 (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), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04041609 phase2completednot on this map

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)

TypeinterventionalSponsorLyra TherapeuticsRan2019 to 2021Enrolled71ConditionsChronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)ArmsLYR-210, Sham comparator
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Perspectives in Therapy of Chronic Rhinosinusitis.Diagnostics (Basel, Switzerland) · 2022
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Anders CervinUniversity of Queensland Centre for Clinical Research, Royal Brisbane & Women's Hospital Campus, Herston, QLD, Australia.
Joanne RimmerMonash Health and Department of Surgery, Monash University, Melbourne, VIC, Australia.
Agnieszka WrobelCentrum Medyczne, AllMed, Lodz, Poland.
Yogen AbelakVistaMed Sp. z o.o., Rzeszów, Poland.
Lindsay BraytonLyra Therapeutics, Inc, Watertown, MA.
Yina KuangLyra Therapeutics, Inc, Watertown, MA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTopical steroids are first-line treatment for chronic rhinosinusitis (CRS), but fail to provide adequate symptom control for all patients. Designed for medical treatment failures, LYR-210 is an implantable matrix that locally elutes mometasone furoate to inflamed sinonasal tissue for up to 24 weeks in CRS patients. In an open-label phase 1 study, LYR-210 demonstrated clinically relevant improvement in the 22-item Sino-Nasal Outcome Test (SNOT-22). Safety and efficacy of LYR-210 in CRS were evaluated in the LANTERN Phase 2 study.

methodsSixty-seven surgically naive adult CRS patients who were inadequately controlled by previous medical management and seeking an alternative treatment enrolled in a multicenter, blinded, controlled, dose-ranging study. Patients had moderate-to-severe disease based on SNOT-22 and composite 7-day average scores of the 4 cardinal CRS symptoms (4CS), with diagnosis confirmed by nasal endoscopy and magnetic resonance imaging. Patients were randomized (1:1:1) to saline irrigation-only control or bilateral in-office administration of LYR-210 (2500 μg) or LYR-210 (7500 μg). Safety and efficacy were evaluated over 24 weeks.

resultsBoth LYR-210 doses were safe and well-tolerated over the 24-week treatment period. LYR-210 demonstrated rapid and durable dose-dependent symptom improvement based on 4CS and SNOT-22, with LYR-210 (7500 μg) achieving statistical significance as early as 8 weeks and out to 24 weeks compared with control. LYR-210 (7500 μg) reduced rescue treatment use and radiographic ethmoid opacification at week 24.

conclusionsLYR-210 is the first implantable sinonasal treatment to achieve up to 24 weeks of benefit from a single administration in surgically naive CRS patients with and without nasal polyps.

Indexed as

Nasal PolypsRhinitisSinusitisAdrenal Cortex HormonesAdultChronic DiseaseHumansTreatment OutcomeAdrenal Cortex Hormoneschronic sinusitislocal drug deliverymometasone furoatenasal polypssinus proceduresurgically naive

Identifiers

PMID34534410
PMCPMC9292908

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.