Phase 2 Chronic Rhinosinusitis Trial, Recruiting NCT05882903 Sponsor: Oticara Australia PTY LTD Condition: Chronic Rhinosinusitis
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Phase 2 Chronic Rhinosinusitis Trial, Recruiting

NCT05882903
Recruiting 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 are an adult (aged 18 to under 80) who has been diagnosed with chronic rhinosinusitis (a long-term sinus condition) by an ear, nose and throat (ENT) specialist.
  • You are currently receiving the maximum recommended medical treatment for your sinus condition as part of your normal care.
  • You have had sinus surgery (called FESS – a procedure to open up the sinuses using a small camera) at least 6 months before joining the study.
  • A camera examination of your nose has shown that any nasal polyps (small growths inside the nose) are small to moderate in size — not completely blocking your nasal passage.
  • The examination has confirmed that key parts of your sinuses are visible and accessible for treatment.
  • You rate your condition as more than 2 out of 10 on a symptom severity scale at the time of screening.
  • You weigh at least 40 kg and have a BMI of 39 or below at the screening visit.
  • If you are able to become pregnant, you must be willing to use a reliable form of contraception and not plan to become pregnant during the study.
  • You are willing and able to give written consent and follow all study requirements.

Who may not be able to join:

  • You have a known allergy or sensitivity to betamethasone dipropionate, mometasone, or local anaesthetic agents (medicines used in this treatment).
  • You have nasal or sinus abnormalities, other nasal conditions, or implanted devices in the nose/sinuses that would prevent the treatment from being given.
  • You have previously taken part in this same study.
  • You are currently taking, or have taken in the past 4 weeks, steroid tablets or injections that work throughout your whole body, or you are currently receiving biologic therapy (a type of medication that targets specific parts of the immune system).
  • You have a history of glaucoma or cataracts, or your eye pressure was found to be higher than normal (above 21 mmHg) at your screening appointment.
  • You currently have an acute (sudden or severe) sinus infection.
  • You have a known problem with your immune system that reduces your ability to fight infections.
  • You have Type 1 diabetes.
  • You have cystic fibrosis.
  • You are pregnant, trying to become pregnant, or currently breastfeeding, as the effects of this treatment on pregnancy are not yet known.
  • You are unable to give informed consent due to mental illness, dementia, or difficulties with communication.
  • You have been diagnosed with Cushing's disease (a hormonal condition) within the past 12 months.
  • You have a severely deviated nasal septum (a significant bend in the wall between your nostrils) or have had a complete removal of a specific nasal structure called the middle turbinate.
  • You have any abnormal test results or other health conditions that the study doctor feels would make participation unsuitable (confirm with trial site).
  • The study doctor believes you are unlikely to be able to follow all study procedures and requirements.

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

Phone: +1 279-217-0054

Australian sites

Oticara Investigational Site, Sydney, New South Wales
Oticara Investigational Site, Brisbane, Queensland
Oticara Investigational Site, Adelaide, South Australia
Oticara Investigational Site, Perth, Western Australia

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

Status
Recruiting
Phase
Phase 2
Sponsor
Oticara Australia PTY LTD
Registry
ClinicalTrials.gov
Start date
17 August 2023
Est. completion
1 June 2025

Where this trial is recruiting

🇦🇺 Australia

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

Primary endpoints

Change in 4-Cardinal Symptom score (4CSS) Baseline to Week 3.; Change in SNOT-22 Baseline to Week 3.

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