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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 below
Select...
I have had symptoms like nasal blockage or loss of smell for over 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

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 more

Side effects data

From 2021 Phase 2 trial • 71 Patients • NCT04041609
17%
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

Background therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05295459 — Phase 3
Chronic Sinusitis Research Study Groups: LYR-210, Sham procedure control
Chronic Sinusitis Clinical Trial 2023: Background therapy Highlights & Side Effects. Trial Name: NCT05295459 — Phase 3
Background therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05295459 — Phase 3
~0 spots leftby Dec 2024