Chronic Rhinosinusitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Part A (before sinus surgery)

• Adults between 18 and 65 years old.
• People who have been diagnosed with chronic sinusitis with nasal polyps (a long-term sinus condition where growths form inside the nose).
• People whose nasal polyp tissue has been tested and confirmed to contain a high level of a specific type of immune cell called eosinophils (confirm with trial site for exact laboratory thresholds).
• People who are already scheduled for a type of sinus surgery (called FESS) because standard medical treatment has not worked well enough for more than 3 months, whose polyp scores meet a specific threshold on both sides of the nose, and who have at least 2 of these symptoms: blocked or congested nose, nasal discharge (front or back of nose), facial pain or pressure, or reduced/lost sense of smell.
• People who are willing to take part voluntarily, sign a consent form, and attend follow-up appointments and complete questionnaires.

Part B (after sinus surgery)

• Adults between 18 and 65 years old.
• People who have been diagnosed with chronic sinusitis with nasal polyps.
• People whose nasal polyp tissue has been tested and confirmed to contain a high level of eosinophils (confirm with trial site for exact laboratory thresholds).
• People who are more than 3 months past their sinus surgery, are on standard ongoing treatment, currently have no visible nasal polyps, but do show signs of early changes such as swelling and discharge inside the sinus passages at specific assessed levels (confirm with trial site).
• People who are willing to take part voluntarily, sign a consent form, and attend follow-up appointments and complete questionnaires.

Who may not be able to join:

Part A

• People who have had nasal surgery in the 6 months before screening that changed the structure inside the nose in a way that prevents polyp assessment.
• People who have a known allergy to corticosteroids (a type of anti-inflammatory medicine) or to any part of the dissolvable medicated stent used in this trial.
• People with a serious illness that would make having surgery unsafe.
• People with other significant nasal or sinus conditions, such as a sinus tumour or a fungal sinus infection.
• People with poorly controlled serious health conditions such as severe heart, liver, or kidney problems, or uncontrolled diabetes.
• People who have recently used certain medicines, including steroid injections, oral steroids, steroid drops or rinses, steroid inhalers, immune-suppressing medicines, biologic medicines, or certain allergy medicines, within specified time periods before the study begins (confirm exact timeframes with trial site).
• People who have had a recent sudden (acute) sinus infection.
• People who have a physical blockage inside the nose that would prevent a medical device from being placed in the sinus area.
• People with a known history of glaucoma, high eye pressure, or a certain type of eye lens problem called a posterior subcapsular cataract.
• People who are pregnant or currently breastfeeding.
• People who have taken part in another clinical trial within the past month.

Part B

• People whose nasal polyps have already returned after surgery (where polyps are detected on either side of the nose).
• People who have used oral steroid tablets at any point after their last sinus surgery.
• People who have a known allergy to corticosteroids or to any part of the dissolvable medicated stent used in this trial.
• People with other significant nasal or sinus conditions, such as a sinus tumour or a fungal sinus infection.
• People with poorly controlled serious health conditions such as severe heart, liver, or kidney problems, or uncontrolled diabetes.
• People who have recently used certain medicines, including steroid injections, oral steroids, steroid drops or rinses, steroid inhalers, immune-suppressing medicines, biologic medicines, or certain allergy medicines, within specified time periods before the study begins (confirm exact timeframes with trial site).
• People who have had a recent sudden (acute) sinus infection.
• People who have a physical blockage inside the nose that would prevent a medical device from being placed in the sinus area.
• People with a known history of glaucoma, high eye pressure, or a certain type of eye lens problem called a posterior subcapsular cataract.
• People who are pregnant or currently breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.