Evidence map›Paper›PMID 35708181›Full record

Trial reportAmerican journal of rhinology & allergy2022

Pharmacokinetic Evidence of Steady and Sustained Drug Release from Long-Acting Implantable Corticosteroid Matrices for Chronic Rhinosinusitis.

Randall A Ow, Steven Shotts, Venkata Kakarlapudi, John McIntyre, Robert M Naclerio, Changcheng You, Alexander Pappas, Lindsay Brayton, Yina Kuang, James Shao

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of rhinology & allergy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.6field-weighted citation impact, top 34% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 4 citations in OpenAlex.

No citing paper in PubMed yet.

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

10 authors at 5 institutions in 1 country.

Randall A OwSacramento Ear, Nose, and Throat, Roseville, California.
Steven ShottsAdvanced ENT and Allergy, Louisville, Kentucky.
Venkata KakarlapudiAdvanced ENT and Allergy, New Albany, Indiana.ORCID 0000-0001-6694-4598
John McIntyreFort Worth ENT, Fort Worth, Texas.
Robert M Naclerio310950Johns Hopkins University, Baltimore, Maryland.
Changcheng YouLyra Therapeutics, Inc., Watertown, Massachusetts.ORCID 0000-0001-9227-5711
Alexander PappasLyra Therapeutics, Inc., Watertown, Massachusetts.
Lindsay BraytonLyra Therapeutics, Inc., Watertown, Massachusetts.
Yina KuangLyra Therapeutics, Inc., Watertown, Massachusetts.
James ShaoLyra Therapeutics, Inc., Watertown, Massachusetts.
Lyndra Therapeutics (United States) · USAdvanced ENT and Allergy · USCarolina Ear, Nose and Throat Clinic · USFort Worth Library · USJohns Hopkins University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy of topical corticosteroids is limited in chronic rhinosinusitis (CRS) due to rapid clearance from the nasal cavity and insufficient drug delivery to inflamed sinonasal passages. LYR-210 is an implantable corticosteroid matrix designed to provide up to 24 weeks of treatment to patients with CRS by locally delivering mometasone furoate (MF) to the sinonasal mucosa. In a randomized, controlled, dose-ranging LANTERN study, LYR-210 (7500 µg) achieved clinically relevant improvement in CRS cardinal symptom composite scores, the 22-item Sinonasal Outcome Test (SNOT-22), ethmoid opacification, and the need for rescue treatment at 24 weeks.

objectiveAs the plasma MF concentrations of LYR-210 (2500 µg) and LYR-210 (7500 µg) were evaluated at weeks 4, 12, and 24 in the LANTERN study (data on file at Lyra Therapeutics, Inc.), this study aims to characterize the pharmacokinetic profiles of both doses of LYR-210 at earlier timepoints post-placement in patients with CRS.

methodsTwenty-four surgically naïve adult patients with CRS were enrolled in an open-label, multicenter study and underwent in-office bilateral administration of LYR-210 (2500 µg) (

resultsBoth LYR-210 doses were well-tolerated with no serious adverse events. Systemic MF levels were dose-dependent and lower than reported values of other respiratory MF products. Plasma MF concentrations showed steady drug release from LYR-210 (2500 µg) and LYR-210 (7500 µg) that persisted through day 56.

conclusionLYR-210 achieved dose-dependent, continuous local MF delivery at a steady rate with low systemic exposure for months.

Indexed as

PregnadienediolsSinusitisAdrenal Cortex HormonesAdultChronic DiseaseDrug LiberationHumansMometasone FuroatePharmaceutical PreparationsTreatment OutcomeAdrenal Cortex HormonesMometasone FuroatePharmaceutical PreparationsPregnadienediolschronic rhinosinusitisclinical studycontrolled drug releasedrug deliverydrug matrixin-office proceduremiddle meatusmometasone furoateplasma pharmacokineticssinonasal mucosa

Identifiers

PMID35708181
PMCPMC9549255
OpenAlexW4282967730

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.