LYR-210 for Chronic Sinusitis

Verified Trial

Phase 3

Waitlist Available

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 week 24

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 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) of nasal blockage/obstruction/congestion, anterior/posterior nasal discharge, and facial pain/pressure at Week 24 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 7-day average composite score of 3CS at Week 24.

CFBL in the percent opacification of the bilateral anterior and posterior ethmoids at Week 20, as determined by 3-D volumetric CT analysis.

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