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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04041609
Recruitment Status : Active, not recruiting
First Posted : August 1, 2019
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Lyra Therapeutics

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.

Condition or disease Intervention/treatment Phase
Chronic Sinusitis Chronic Rhinosinusitis (Diagnosis) Drug: LYR-210 Other: Sham comparator Phase 2

Detailed Description:
LYR-210 is a combination product comprised of 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : May 23, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
Active Comparator: LYR-210 (Low Dose)
In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus
Drug: LYR-210
Management of Chronic Sinusitis in Adult Patients with nasal polyps (CSwNP) and without nasal polyps (CSsNP)

Active Comparator: LYR-210 (High Dose)
In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus
Drug: LYR-210
Management of Chronic Sinusitis in Adult Patients with nasal polyps (CSwNP) and without nasal polyps (CSsNP)

Sham Comparator: Sham Procedure
In-office bilateral sham procedure
Other: Sham comparator
Sham comparator




Primary Outcome Measures :
  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 Outcome Measures :
  1. To evaluate the effect of LYR-210 in improving CS disease-specific quality of life as per 22-item sino-nasal outcome test (SNOT-22) questionnaire for up to 24 weeks [ 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. CFBL in imaging 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. The ostiomeatal complex (OMC) is given a score of 0 to 2 as follows: 0 = completely patent, 1 = partially occluded, 2 = completely occluded. Each sinus pair has a bilateral score in the range of 0 to 10, and the OMC pair in the range of 0 to 4, and the total sum of all sinuses and OMCs in the range of 0-54. Higher scores indicate higher severity of sinus opacification.

  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 for up to 24 weeks [ Time Frame: 24 weeks ]
    To evaluate the pharmacokinetics of LYR-210



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04041609


Locations
Show Show 22 study locations
Sponsors and Collaborators
Lyra Therapeutics
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Responsible Party: Lyra Therapeutics
ClinicalTrials.gov Identifier: NCT04041609    
Other Study ID Numbers: LYR-210-2018-002
2018-004621-89 ( EudraCT Number )
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All Individual Participant Data (IPD) that underlie results in a publication may be available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes