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Study on the Effectiveness and Safety of LYR-210 and Dexamethasone for Treating Chronic Sinusitis in Adults Without Nasal Polyps

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Chronic Rhinosinusitis (CRS) in adults. CRS is a condition where the sinuses, which are air-filled spaces in the face, become inflamed and swollen for a long time, leading to symptoms like nasal blockage, facial pain, and nasal discharge. The study will evaluate a treatment called the LYR-210 System, which is a powder for inhalation containing the active substance Mometasone Furoate. This treatment is compared to a sham procedure, which is a fake treatment used for comparison purposes.

The purpose of the study is to assess how effective the LYR-210 System is in improving the main symptoms of CRS in participants who do not have nasal polyps and have not responded well to previous medical treatments. Participants will receive the treatment through intranasal use, meaning it is administered through the nose. The study will last for about 24 weeks, during which the changes in symptoms will be monitored and compared to the initial state before the treatment started.

Another medication involved in the study is Dexamethasone, which is a tablet form of a chemical substance used in various treatments. However, the main focus of this trial is on the LYR-210 System. Participants will be monitored for any changes in their symptoms and overall health to determine the safety and effectiveness of the treatment. The study aims to provide valuable information on whether the LYR-210 System can be a beneficial treatment option for those suffering from chronic sinusitis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after providing written consent and agreeing to comply with all study requirements.

    Eligibility includes being 18 years or older, having a diagnosis of chronic rhinosinusitis (CRS), and having undergone at least two previous medical treatments.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm bilateral ethmoid disease using a computed tomography (CT) scan.

    A baseline measurement of the three cardinal symptoms (3CS) of CRS is recorded, which includes nasal blockage, facial pain, and nasal discharge.

  3. Step 3

    Treatment administration

    The treatment involves the use of the LYR-210 System, which is administered intranasally.

    The system is designed to deliver medication directly to the nasal passages over a specified period.

  4. Step 4

    Medication details

    The active substances used in the treatment are dexamethasone and mometasone furoate.

    These medications are administered as a powder for inhalation.

  5. Step 5

    Monitoring and follow-up

    Participants are monitored regularly to assess the change from baseline in the 7-day average composite score of the 3CS at Week 24.

    Secondary assessments include changes in individual symptom scores and the Sino-Nasal Outcome Test (SNOT-22) score.

  6. Step 6

    Completion of the study

    The study is estimated to conclude by December 17, 2024.

    Final assessments will determine the efficacy and safety of the LYR-210 treatment for chronic rhinosinusitis.

Who can join the trial?

8 criteria

  • Must be **18 years or older**.
  • Must have been **diagnosed with Chronic Rhinosinusitis (CRS)**. This is a condition where the spaces inside your nose and head (sinuses) are swollen and inflamed for a long time.
  • Must have **bilateral ethmoid disease** confirmed by a **CT scan**. This means that both sides of the ethmoid sinuses, which are located between your eyes, show signs of disease on a special type of X-ray called a CT scan.
  • Must have a certain level of **3 cardinal symptom (3CS) score**. This score measures the severity of three main symptoms of CRS.
  • Must have tried at least **two different medical treatments** in the past.
  • Must have been **informed about the study** and have given **written consent** to participate. This means you understand what the study involves and agree to take part.
  • Must agree to **follow all study requirements**.
  • Must be **willing to cancel or postpone any planned sinus surgery** while participating in the study.

Who cannot join the trial?

6 criteria

  • Patients with **nasal polyps** cannot participate. Nasal polyps are soft, painless growths inside the nose or sinuses.
  • Patients who have not previously tried medical treatments for their condition are excluded. This means if you haven't tried medications or other therapies for your condition, you cannot join.
  • Patients who are not adults are excluded. Only adults can participate in this study.
  • Patients with other significant health issues that might interfere with the study are excluded. This means if you have other serious health problems, you might not be able to join.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
  • Patients who are unable to follow the study procedures or attend the required visits are excluded. This means if you can't commit to the study schedule, you cannot join.
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Investigated drugs

LYR-210 is a medication being tested for its ability to treat chronic rhinosinusitis (CRS) in adults. This medication is designed to help improve the main symptoms of CRS, such as nasal congestion, facial pain or pressure, and nasal discharge. It is intended for patients who have not found relief from other medical treatments.

What is already known about the treatment

LYR-210 – LYR-210 is administered as an implant placed in the nasal cavity, designed to release medication over time directly at the site of inflammation. It is currently being studied in clinical trials for its effectiveness in treating chronic rhinosinusitis (CRS) in adults, particularly those who have not responded to other treatments. The main therapeutic indication for LYR-210 is to alleviate the symptoms of CRS, such as nasal congestion, facial pain, and loss of smell. At the molecular level, it works by delivering anti-inflammatory medication directly to the affected tissues, reducing inflammation and improving sinus drainage. LYR-210 is classified pharmacologically as a local anti-inflammatory treatment.

Investigated diseases

Chronic Rhinosinusitis (CRS) in Adults – This condition is characterized by inflammation of the sinuses and nasal passages lasting for at least 12 weeks. It often results in symptoms such as nasal blockage, facial pain or pressure, and nasal discharge. The inflammation can lead to a feeling of congestion and difficulty breathing through the nose. CRS can occur with or without nasal polyps, which are non-cancerous growths in the nasal passages. The disease can significantly affect the quality of life due to persistent discomfort and breathing difficulties. It is often resistant to standard medical treatments, requiring ongoing management.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506268-15-00Protocol codeLYR-210-2021-005Estimated enrolment184 patientsSponsorLyra Therapeutics Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).