Phase 2 Chronic Rhinosinusitis Trial, Recruiting

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

Who might be able to join this trial:

• People aged between 18 and 75 years (inclusive), of any sex
• People with a Body Mass Index (BMI) of at least 18.5 (BMI is a measure of body weight relative to height)
• People who have been diagnosed with chronic rhinosinusitis (long-term inflammation of the sinuses and nasal passages) according to specific Chinese clinical guidelines, with symptoms lasting more than 12 weeks
• People whose nasal examination during the screening period shows signs of inflammation (such as swelling or pus) on both sides of the nose, or whose CT scan shows involvement of sinuses on both sides
• People whose CT scan during screening shows sinus involvement on both sides, with at least one sinus on each side reaching a minimum score on a standard sinus severity scale (called the Lund-MacKay scale)
• People whose nasal blockage is rated at 2 or more points on a standard scoring scale during screening
• People whose combined symptom score for nasal blockage, runny nose, and facial pain or pressure adds up to 5 or more points during screening
• People whose score on a standard sinus and nasal symptom questionnaire (called SNOT-22) is 20 or more points during screening
• People who have been using a specific nasal steroid spray (mometasone furoate nasal spray) at a steady daily dose for at least 4 weeks before joining the trial
• People with asthma or a chronic lung condition (COPD) may be eligible if their condition has been stable — with no serious flare-ups, hospital visits, or need for steroid tablets — for at least 3 months before screening, and if they have been on a steady dose of inhaled steroids for at least 3 months with plans to continue throughout the trial
• People who fully understand the trial and voluntarily agree to take part by signing a consent form (or have an authorised representative do so on their behalf)

Who may not be able to join:

• People who have nasal polyps (growths inside the nose) confirmed by examination, or who have had nasal polyps in the past
• People who need to take steroid tablets or injections regularly as ongoing treatment during the screening period
• People diagnosed with cystic fibrosis or a condition affecting the tiny hair-like structures in the airways (primary ciliary dyskinesia)
• People who have had nasal surgery within 4 weeks before screening, or who are expected to need sinus surgery during the trial
• People with significant structural abnormalities of the face or skull, or a severely deviated nasal septum (the wall dividing the two sides of the nose)
• People whose scans suggest or confirm certain serious sinus conditions, including invasive fungal infection, tooth-related sinus disease, bone growths, or nasal tumours
• People with other conditions or illnesses that could interfere with measuring the trial's main outcomes — for example, seasonal hay fever with symptoms overlapping the study period, moderate to severe eczema requiring certain treatments, or an acute respiratory infection that the trial doctor believes would affect symptom scores
• People who have had an acute infection requiring antibiotic treatment within 4 weeks before screening
• People with inflammatory or autoimmune conditions (including immune deficiency diseases) that require biologic therapies or medications that suppress the immune system
• People with a known allergy or intolerance to any ingredient in the trial medication or the background treatment used in the study
• People with a past or current diagnosis of periodontitis (serious gum disease) or a specific inherited skin condition affecting the palms and soles linked to a particular enzyme deficiency (DPP1), or people who show signs of gum disease or this skin condition at screening
• People who have taken certain medications that can cause skin thickening (such as TNF-α blockers) within 4 weeks before screening
• People who have taken certain medications known to strongly affect how the body processes drugs (strong CYP3A4 or CYP2D6 inhibitors or inducers) within 14 days before the first trial dose (confirm with trial site)
• People whose liver function blood tests during screening are significantly above normal levels and who are currently receiving treatment for liver disease
• People who test positive during screening for hepatitis B, hepatitis C, HIV, or syphilis
• Current smokers (defined as people who have smoked at least 100 cigarettes in their lifetime and are still smoking), or people who are unwilling or unable to avoid smoking for the duration of the trial
• People who have taken part in another drug or medical device trial within 3 months before this trial, or who are currently enrolled in another clinical trial
• Male participants who plan to donate sperm or father a child from the start of dosing until 90 days after the last dose and are unwilling to use effective non-hormonal contraception during that period
• Female participants who plan to donate eggs or become pregnant from the start of dosing until 30 days after the last dose and are unwilling to use effective non-hormonal contraception during that period
• People who are pregnant or breastfeeding
• People whom the trial doctor considers unsuitable for the study for any reason

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