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

L

Lyra Therapeutics

Status and phase

Completed
Phase 2

Conditions

Chronic Sinusitis
Chronic Rhinosinusitis (Diagnosis)

Treatments

Drug: LYR-210
Other: Sham comparator

Study type

Interventional

Funder types

Industry

Identifiers

NCT04041609
2018-004621-89 (EudraCT Number)
LYR-210-2018-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

71 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

71 participants in 3 patient groups

LYR-210 (Low Dose)
Experimental group
Description:
In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus
Treatment:
Drug: LYR-210
LYR-210 (High Dose)
Experimental group
Description:
In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus
Treatment:
Drug: LYR-210
Sham Procedure
Sham Comparator group
Description:
In-office bilateral sham procedure
Treatment:
Other: Sham comparator

Trial documents
2

Trial contacts and locations

22

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Data sourced from clinicaltrials.gov

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