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LYR-210 for Chronic Sinusitis
Verified Trial
Phase 3
Recruiting
Research Sponsored by Lyra Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have you experienced 2 or more of the following CRS symptoms for at least 3 months: Nasal congestion/blockage, runny nose/post-nasal drip, facial pain/pressure, and loss/reduction of sense of smell.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Pivotal Trial
Summary
This trial is designed to compare the efficacy of two treatments by randomly assigning patients to receive either one or the other. The trial will be conducted at multiple centers, will involve at least three phases, will be blinded (meaning that the patients will not know which treatment they are receiving), and will be controlled (meaning that there will be a control group of patients who receive no treatment).
Who is the study for?
This trial is for adults with chronic sinusitis confirmed by a CT scan, who have not had sinus surgery. Participants should be experiencing symptoms like nasal blockage, runny nose, facial pain, or loss of smell for at least 3 months and these should significantly affect their daily life. They must have used steroid nasal sprays for at least 4 weeks.
What is being tested?
The study is testing LYR-210 against a sham procedure to see if it's better in treating chronic sinusitis when added to regular background therapy. It's a large-scale phase III trial where participants are randomly assigned to either the test drug or control group without knowing which one they're getting.
What are the potential side effects?
While specific side effects aren't listed here, treatments like LYR-210 could potentially cause local irritation or discomfort, allergic reactions, headache, nosebleeds or increase the risk of infections due to its action on the immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had symptoms like nasal blockage or loss of smell for over 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline (CFBL) in the 7-day average composite score of 3 cardinal symptoms (3CS) in participants without nasal polyps.
Secondary study objectives
CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) total score at Week 24.
CFBL in the 3-D volumetric CT score at Week 20.
CFBL in the 7-day average CS score of anterior/posterior nasal discharge at Week 24.
+4 moreSide effects data
From 2021 Phase 2 trial • 71 Patients • NCT0404160917%
Chronic Sinusitis
17%
Rhinitis
13%
Epistaxis
9%
Rhinorrhoea
9%
Facial Pain
4%
Upper respiratory tract infection
4%
Oropharyngeal pain
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
LYR-210 (High Dose)
LYR-210 (Low Dose)
Sham Procedure
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LYR-210Experimental Treatment2 Interventions
Single administration of LYR-210 drug matrix (7500 μg)
Group II: Sham procedure controlPlacebo Group2 Interventions
Single mock administration procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LYR-210
2022
Completed Phase 3
~270
Find a Location
Who is running the clinical trial?
Lyra TherapeuticsLead Sponsor
4 Previous Clinical Trials
337 Total Patients Enrolled
4 Trials studying Chronic Sinusitis
337 Patients Enrolled for Chronic Sinusitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with CRS.I have never had sinus surgery.I have been diagnosed with or am being diagnosed for chronic sinusitis.I have had symptoms like nasal blockage or loss of smell for over 3 months.My CRS symptoms significantly affect my daily life.I have used steroid nasal sprays for at least 4 weeks.My average symptom score is relevant.
Research Study Groups:
This trial has the following groups:- Group 1: LYR-210
- Group 2: Sham procedure control
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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