Phase 2 Chronic Rhinosinusitis Trial, Completed NCT04041609 Sponsor: Lyra Therapeutics Condition: Chronic Rhinosinusitis
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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 (NCT04041609) enrolled 71 adults with chronic sinusitis across three groups: 24 received a low dose of LYR-210 (an implantable device placed in the sinuses), 23 received a high dose of LYR-210, and 24 underwent a sham (dummy) procedure for comparison. The trial measured changes in sinusitis symptom scores, quality-of-life questionnaire scores, sinus imaging scores, and the number of participants who experienced side effects thought to be related to the treatment, over a period of up to 24 weeks. Not everyone completed the study — 17, 15, and 17 participants finished in the low-dose, high-dose, and sham groups respectively. The reported data shows that at week 4 — the main measurement point — average symptom scores (rated 0–3 per symptom, with higher meaning worse) fell by 2.24 points in the low-dose group, 2.65 points in the high-dose group, and 2.28 points in the sham group, all measured from where participants started. By week 24, the reported drops in symptom scores were larger: 3.36 (low dose), 4.32 (high dose), and 2.68 (sham). A separate quality-of-life questionnaire (scored 0–110, higher meaning worse) showed average reductions of 30.0 points (low dose), 40.7 points (high dose), and 21.7 points (sham) by week 24. For sinus imaging, 13 participants in the low-dose group, 14 in the high-dose group, and 10 in the sham group showed at least a small improvement in how blocked their sinuses appeared on scans. The reported data also shows that the number of participants who experienced side effects considered possibly related to the treatment was 11 in the low-dose group, 5 in the high-dose group, and 5 in the sham group. Blood drug-level measurements at week 4 were only reported for the two LYR-210 groups (13.6 and 45.4 picograms per millilitre for low and high dose respectively); no figure was reported for the sham group, as participants in that group did not receive the active device. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

NCT04041609
Completed Phase 2 🇦🇺 Australian site

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 sinusitis (CS).
  • You have already tried at least two different medical treatments for chronic sinusitis in the past.
  • Your chronic sinusitis symptoms meet a minimum level of severity required by the trial.
  • You are able to tolerate numbing medicine applied to the skin or tissue (topical anesthesia).
  • 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 throughout the trial.

Who may not be able to join:

  • You have had surgery on your sinuses before.
  • You are currently pregnant or breastfeeding.
  • You have a known allergy or bad reaction to corticosteroid (steroid) medications.
  • You have a history or signs of certain types of fungal sinus infections, or a condition where the lining of the nose has wasted away (confirm with trial site).
  • You have a known problem with how your body produces hormones involving the brain and adrenal glands, or your morning cortisol (a stress hormone) level was outside the normal range at your screening test.
  • You have had a dental procedure or implant involving your upper teeth within the last 4 weeks before screening.
  • You currently have, or have had, useful vision in only one eye.
  • You have cataracts (clouding of the lens in your eye).
  • You have had, currently have, or are planning to have an organ transplant, or are receiving chemotherapy that suppresses the immune system.
  • You are currently taking part in another clinical trial involving an investigational 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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Australian sites

Royal Brisbane and Woman's Hospital, Brisbane,
Monash Health, Clayton,
The ENT Centre, Hornsby,
Westmead Hospital, Westmead,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 2
Sponsor
Lyra Therapeutics
Registry
ClinicalTrials.gov
Start date
9 May 2019
Est. completion
25 March 2020

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇨🇿 Czechia 🇳🇿 New Zealand 🇵🇱 Poland

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov