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Completed

NCT Number: NCT04041609

LYR-210 Depot (LYR-210) for 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.

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Key information

Conditions

Chronic Sinusitis Chronic Rhinosinusitis (Diagnosis) Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Brisbane and Woman's Hospital, Brisbane, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LYR-210

Drug

A single administration of LYR-210 depot

Sham Comparator

Other

Sham comparator

Primary outcomes

  1. Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4

    Time frame: 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.

Secondary outcomes

  1. Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24

    Time frame: 24 weeks

    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.

  2. CFBL in Chronic Sinusitis Symptom Scores at Week 24

    Time frame: 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.

  3. Participants With Improved Bilateral Zinreich Score at Week 24

    Time frame: 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.

  4. The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks

    Time frame: 24 weeks

    To evaluate the safety and tolerability of LYR-210

  5. Plasma Drug Concentrations of MF at Week 4

    Time frame: 4 Weeks

    To evaluate the pharmacokinetics of LYR-210

  6. Plasma Drug Concentrations of MF at Week 12

    Time frame: 12 weeks

    To evaluate the pharmacokinetics of LYR-210

Sponsors and collaborators

Lead sponsor

Lyra Therapeutics

Industry

Registry information

Official study title

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)

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Aug 1, 2019
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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