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

3 1 1 1

What is this study about?

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.

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 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 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 medication details

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

These medications are administered as a powder for inhalation.

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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
HNO-Praxis Landsberg Landsberg Am Lech Germany
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
FARMA -MED. Kujawskie Centrum Medyczne Spółka z o.o.; Inowroclaw Poland

Other Sites

Site Name City Country Status
Bajcsy-Zsilinszky Korhaz Es Rendelointezet Budapest Hungary
Mazowiecki Szpital Brodnowski Sp. z o.o. Warsaw Poland
Promed P.Lach R.Glowacki Sp. j. Cracow Poland
University Of Pecs Pecs Hungary
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
Universitair Ziekenhuis Gent Gent Belgium
Komarom-Esztergom Varmegyei Szent Borbala Korhaz Tatabanya Hungary
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Diagnostics-Consultancy Center Mladost M Varna OOD Varna Bulgaria
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz Budapest Hungary
Budapesti Uzsoki Utcai Korhaz Budapest Hungary
Semmelweis University Budapest Hungary
Vtgpvsah &lmby Vukgwfb Snb z oqrf Wroclaw Poland
Ppxycwlx Pryyxdwj Lfkhlcoj &coggvt Ajiinct Sywtrrgkhoz Bialystok Poland
Kbxgcg Gxqo Bad Schönborn Germany
Cleoaaexr Ufakfgqkjiamyl Seqvvrpkq Woluwe-Saint-Lambert Belgium
Pelyxtkud Iofkigke Mypzlqfb Mijxklaryooj Simkv Wrjtbjesdibw I Amnyghtwoxwnd Warsaw Poland
Mkpbvldb Mmocuug Axezhin Pleven Bulgaria
Mdinmat Ctbedd Mbsikcibbn &tjkeel Bgnaqa Burgas Bulgaria
Mnbmdxz Csinxp Htrzifskf Dzawduj Fjqrly Budapest Hungary

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
17.08.2022
Bulgaria Bulgaria
Not recruiting
17.08.2022
Germany Germany
Not recruiting
17.08.2022
Hungary Hungary
Not recruiting
17.08.2022
Poland Poland
Not recruiting
17.08.2022

Trial locations

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.

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 ID:
2023-506268-15-00
Protocol code:
LYR-210-2021-005
NCT ID:
NCT05295459
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on Azithromycin for Treating Chronic Sinusitis in Adults

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    France