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Completed

NCT Number: NCT05219968

Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults

Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.

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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 3

Primary location

Lyra Investigational Site, Graz, Austria

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About this study

This is a 52-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period followed by a safety extension phase with crossover or continued treatment to evaluate the efficacy and safety of LYR-210 compared with sham control for treatment in adults with CRS.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18
  • Diagnosed as having CRS
  • Undergone at least 2 trials of medical treatments in the past
  • Mean 3 cardinal symptom (3CS) score
  • Bilateral ethmoid disease confirmed on CT
  • Has been informed of the nature of the study and provided written informed consent
  • Agrees to comply with all study requirements
  • If on a waiting list for sinonasal surgery, willing to be removed from list or have surgery date cancelled for the duration of the study.

Exclusion criteria

  • Inability to tolerate topical anesthesia or endoscopic procedure
  • Previous nasal surgery
  • Presence of nasal polyp grade 2 or higher
  • Seasonal allergic rhinitis
  • Perennial rhinitis with symptoms that are well controlled by regular use of intranasal corticosteroids
  • Severe asthma
  • History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis
  • Obstruction preventing proper placement and retention of LYR-210 as seen on endoscopy
  • Anatomic variation that, in the opinion of the investigator, would adversely impact placement of LYR-210 as seen on CT
  • Known history of hypersensitivity or intolerance to corticosteroids
  • Known history of hypothalamic pituitary adrenal axial dysfunction
  • Previous pituitary or adrenal surgery
  • Dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
  • Past or present acute or chronic intracranial or orbital complications of CRS
  • History or diagnosis (in either eye) of glaucoma or ocular hypertension
  • Past or present functional vision in only 1 eye
  • Past, present, or planned organ transplant or chemotherapy with immunosuppression
  • Currently positive for COVID-19 or residual sinonasal symptoms from a previous COVID-19 infection
  • Pregnant or breast feeding. Females of child-bearing potential must test negative for pregnancy at the time of screening
  • Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments
  • Currently participating in an investigational drug or device study
  • Determined by the investigator as not suitable to be enrolled

Treatment and study plan

LYR-210

Drug

LYR-210 drug matrix (mometasone furoate)

Sham procedure control

Drug

Sham procedure control

Background therapy

Other

Daily Saline Irrigation

Primary outcomes

  1. Change From Baseline (CFBL) in the 7-day Average Composite Score of 3 Cardinal Symptoms (3CS) in Participants Without Nasal Polyps.

    Time frame: 24 Weeks

    The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores.

    The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.

Secondary outcomes

  1. CFBL in the 7-day Average Composite Score of 3CS in All Participants at Week 24.

    Time frame: Week 24

    The 3CS are nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure. The diary is completed daily by study participants throughout the study. Each symptom/each question is rated on a 4-point (0-3) scale where 0= none/absent symptoms, 1=mild symptoms, 2=moderate symptoms, and 3=severe symptoms. The composite score of 3CS is the sum of the three cardinal symptom scores.

    The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.

  2. CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) Total Score at Week 24

    Time frame: Week 24

    The SNOT-22 questionnaire is a 22-item disease-specific quality of life instrument. Each symptom is scored on a 6-point scale where 0 = no problem and 5 = problem as bad as it can be. The total SNOT-22 score is the sum of the 22 items and can range from 0 to 110 with higher scores indicating worse symptoms.

  3. CFBL in the 3-D Volumetric CT Score at Week 20

    Time frame: Week 20

    The percent opacification of the bilateral anterior and posterior ethmoids will be assessed by 3-D volumetric CT analysis at baseline and Week 20.

    A negative change from Baseline indicates improvement from Baseline.

  4. Participants With Rescue Treatments for CRS Through Week 24

    Time frame: Week 24

    This endpoint is descriptively summarized per the prespecified plan. This includes participants that used systemic corticosteroid for any reason as well as participants that were recommended/underwent sinonasal surgery.

Sponsors and collaborators

Lead sponsor

Lyra Therapeutics

Industry

Registry information

Official study title

ENLIGHTEN 1: A Phase III, Randomized, Blinded, Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis (CRS) in Adults

Acronym: ENLIGHTEN 1

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 2, 2022
Registry last updated
May 2, 2025

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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