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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05035654
Registration number
NCT05035654
Ethics application status
Date submitted
27/08/2021
Date registered
5/09/2021
Date last updated
17/12/2024
Titles & IDs
Public title
LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)
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Scientific title
BEACON: A Phase II, Patient-blinded, Two-part, Randomized, Parallel-group Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LYR-220 in Chronic Rhinosinusitis (CRS) Patients Who Have Had a Prior Ethmoidectomy
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Secondary ID [1]
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LYR-220-2021-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Sinusitis
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Chronic Rhinosinusitis (Diagnosis)
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LYR-220 Design 1 (Part 1 only)
Treatment: Drugs - LYR-220 Design 2 (Part 1 and Part 2)
Treatment: Drugs - Bilateral sham procedure control (Part 2)
Experimental: Part 1: Treatment Arm LYR-220 Design 1 - Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
Experimental: Part 1 and Part 2: Treatment Arm LYR-220 Design 2 - Bilateral insertion of LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
Sham comparator: Part 2: Treatment Arm Bilateral sham procedure control - Bilateral sham procedure control
Treatment: Drugs: LYR-220 Design 1 (Part 1 only)
LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
Treatment: Drugs: LYR-220 Design 2 (Part 1 and Part 2)
LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
Treatment: Drugs: Bilateral sham procedure control (Part 2)
Bilateral sham procedure control
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Product-related Unexpected Serious Adverse Events
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Assessment method [1]
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Product-related unexpected serious adverse events
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Timepoint [1]
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Through Week 28
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Primary outcome [2]
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Plasma MF Concentrations
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Assessment method [2]
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Plasma MF concentrations at 1 hour post study treatment administration and at Days 2 or 3, days 5 or 8, and Weeks 4,12,16 or 20, 24 and 25. The PK analysis will be performed based on subjects with available plasma MF concentration data post Day 1 administration procedure.
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Timepoint [2]
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Through Week 25
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Secondary outcome [1]
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Adverse Events
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Assessment method [1]
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Percentage of subjects reporting treatment-emergent adverse events
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Timepoint [1]
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Through Week 28
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Secondary outcome [2]
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Endoscopic Findings
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Assessment method [2]
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Percentage of subjects with newly identified or worsened endoscopic findings in the ethmoid cavity (mild, moderate, or severe)
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Timepoint [2]
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Through Week 25
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Secondary outcome [3]
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Ophthalmic Assessment: Intraocular Pressure (IOP)
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Assessment method [3]
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Percentage of subjects with clinically significant increase in IOP
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Timepoint [3]
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Through Week 25
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Secondary outcome [4]
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Ophthalmic Assessment: Cataract
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Assessment method [4]
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Percentage of subjects with newly identified or worsened cataract in one or both eyes
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Timepoint [4]
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Through Week 25
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Secondary outcome [5]
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Improving Chronic Rhinosinusitis (CRS) Specific Quality of Life as Per the 22-item Sino-nasal Outcome Test (SNOT-22) Questionnaire
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Assessment method [5]
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The 22-item Sino-Nasal Outcome Test (SNOT-22) questionnaire is a 22-item disease-specific quality of life instrument validated for use in CRS. Each symptom is scored as it has been over the past 2 weeks on a 6-point scale as follows: 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 outcome measure is change from baseline in total patient-reported outcome score. The SNOT-22 total score is the sum of individual scores and ranges from 0 to 110. Higher scores indicate higher severity of symptoms.
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Timepoint [5]
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Through Week 28
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Secondary outcome [6]
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Change From Baseline in the Average Composite Score Over the Preceeding 7 Days of the 3 Cardinal Symptoms (3CS)
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Assessment method [6]
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Change from baseline in the average composite score over the preceeding 7 days of the 3 Cardinal Symptoms (3CS).The 3CS include: nasal blockage/obstruction/congestion, facial pain/ pressure, and anterior/posterior nasal discharge. The diary is completed daily by study participants throughout the study. Each symptom/each question is scored daily on a 0-3 scale as follows: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The 3CS total score ranges from 0-9, with higher scores indicating worse symptoms.
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Timepoint [6]
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Through Week 28
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Eligibility
Key inclusion criteria
* Diagnosis of chronic rhinosinusitis.
* Has had a prior bilateral total ethmoidectomy.
* Has computed tomography (CT) ethmoid cavity opacification.
* Has a Sinonasal Outcome Test (SNOT-22) = 20 at Screening Visit.
* Minimum cardinal symptom score.
* 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 or regulatory authority if applicable by national law.
* Agrees to comply with all study requirements.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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.
* Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
* Past or present functional vision in only one eye.
* Past, present, or planned organ transplant or chemotherapy with immunosuppression.
* With prior cataract surgery or presence (in either eye) of posterior subcapsular cataract of grade 2 or higher, nuclear cataract of grade 3 or higher, or cortical cataract of grade 2 or higher or involving a minimum of center optic zone of 3 mm diameter.
* Ethmoidectomy that was unilateral or partial.
* Currently participating in an investigational drug or device study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/11/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/08/2023
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Sample size
Target
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Accrual to date
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Final
48
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Lyra Investigational Site - Bedford Park
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Recruitment hospital [2]
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Lyra Investigational Site - Brisbane
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Recruitment hospital [3]
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Lyra Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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5042 - Bedford Park
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Recruitment postcode(s) [2]
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- Brisbane
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Recruitment postcode(s) [3]
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- Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Illinois
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Country [3]
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United States of America
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Indiana
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Country [4]
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United States of America
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State/province [4]
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Kentucky
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Country [5]
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United States of America
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Louisiana
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Country [6]
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Maryland
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Country [7]
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New York
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Country [8]
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North Carolina
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Country [9]
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Pennsylvania
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Country [10]
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State/province [10]
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South Carolina
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Country [11]
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Texas
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Country [12]
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United States of America
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Utah
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United States of America
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State/province [13]
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Washington
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Lyra Therapeutics
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will assess the safety, tolerability, pharmacokinetics and efficacy of two LYR-220 designs in symptomatic adult chronic rhinosinusitis (CRS) subjects who have had a prior functional endoscopic sinus surgery.
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Trial website
https://clinicaltrials.gov/study/NCT05035654
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/54/NCT05035654/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/54/NCT05035654/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05035654
Download to PDF