Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT05035654) enrolled 48 people across three groups to test a device called LYR-220, which is designed to deliver a medication called mometasone furoate (a type of steroid) into the sinus cavity. Three participants were in a group testing an earlier version of the device (Design 1), 24 were in a group testing a refined version (Design 2), and 21 received a sham (dummy) procedure as a comparison group. The trial was primarily measuring how much of the medication entered the bloodstream, and whether any serious unexpected problems related to the product occurred. The reported data shows that across all three groups, zero participants experienced a product-related unexpected serious adverse event — the main safety-related measure the trial was tracking. For blood levels of the medication, the reported data shows that concentrations measured at various time points ranged roughly from around 11 to 136 picograms per millilitre (pg/mL, a very small unit of measurement), varying across the groups and time points. The highest single reported average blood level was 135.83 pg/mL in the Design 2 group. For the secondary (additional) measures, the reported data shows that adverse events (any unwanted health occurrences) were recorded in 1 out of 3 participants in the Design 1 group, 23 out of 24 in the Design 2 group, and 16 out of 21 in the sham group. Newly identified or worsened findings on internal camera examination of the sinus area were reported in 0, 6, and 3 participants respectively. Zero participants in any group were reported to have a clinically significant increase in eye pressure, and cataract changes were reported in 1 participant in the Design 2 group across the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Chronic Rhinosinusitis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with chronic rhinosinusitis (long-term inflammation of the sinuses).
- You have previously had a specific sinus surgery called a bilateral total ethmoidectomy (a complete surgery on the sinus cavities on both sides of the nose).
- A CT scan (a type of detailed X-ray) shows that certain sinus cavities are blocked or filled.
- Your score on a standard sinus symptom questionnaire (called the SNOT-22) is 20 or higher, indicating significant symptoms.
- Your symptoms meet a minimum level of severity as measured by a specific scoring system (confirm with trial site).
- You have been fully informed about the study and have signed a consent form agreeing to take part.
- You are willing and able to follow all of the study's requirements.
Who may not be able to join:
- You are currently pregnant or breastfeeding.
- You have a known allergy or bad reaction to corticosteroids (a type of anti-inflammatory medicine).
- You have a history or signs of certain fungal sinus infections or a condition called atrophic rhinitis (a specific type of nasal condition).
- You have a known history of a condition affecting how your body produces certain hormones (confirm with trial site).
- You have had a dental procedure or implant involving your upper teeth within the last 4 weeks before your screening appointment.
- You have only one eye with functional vision, either now or in the past.
- You have had, currently have, or are planning an organ transplant, or are receiving chemotherapy that weakens the immune system.
- You have had cataract surgery in the past, or currently have certain types or levels of cataracts (clouding of the eye lens) in either eye (confirm with trial site for specific grades).
- Your previous sinus surgery was only on one side or was not a complete removal (partial ethmoidectomy).
- You are currently taking part in another clinical trial for an experimental drug or medical device.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Product-related Unexpected Serious Adverse Events; Plasma MF Concentrations
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.