Phase 3 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:

• People aged 12 to 17 years (inclusive) at the time of the first screening visit.
• Female participants who are sexually active must be using an effective form of contraception (such as oral contraceptives, a patch, an IUD, or a double-barrier method), be surgically unable to become pregnant, or be abstinent.
• Female participants who could potentially become pregnant must have a negative urine pregnancy test at the screening visit.
• People who have had chronic rhinosinusitis (long-term sinus inflammation) and are currently experiencing 2 or more of these symptoms for at least 12 weeks — with at least one being nasal congestion or nasal discharge: nasal congestion, nasal discharge (from the front or back of the nose), facial pain or pressure, or reduced or lost sense of smell.
• People who have medical evidence of nasal lining disease — confirmed by a nasal camera exam showing swelling or infected discharge on both sides, or by a CT scan done within 14 days of the screening visit showing disease on both sides.
• People who have had at least moderate nasal congestion on average during the 7 days before the screening visit, as reported by the participant.
• People who record an average morning congestion score of at least 1.5 on a symptom diary over a 7-day period within the first 14 days of the run-in phase (confirm with trial site).
• People who can correctly complete a daily symptom diary during the run-in period.
• People who also have asthma must have stable asthma, meaning no flare-ups, emergency visits, hospital stays, or steroid tablets/injections in the 3 months before screening — and if using inhaled corticosteroids, must be on no more than a moderate dose for at least 1 month before screening and expected to remain on that dose throughout the study. Note: participants using inhaled fluticasone alone or in combination may not be eligible for a specific sub-study involving drug level monitoring (confirm with trial site).
• People with aspirin-sensitive respiratory disease who have completed aspirin desensitisation and are on daily aspirin therapy must have been on that therapy for at least 6 months before the screening visit.
• People who are able to stop using nasal steroid sprays and inhaled corticosteroids (except permitted asthma doses) at the screening visit.
• People who take oral antihistamines must have been on a stable dose for at least 2 weeks before screening and agree not to change that dose until after Week 4 of the study.
• People who can correctly use the special nasal delivery device; correct use must be demonstrated at the screening visit.
• People (and their parent or guardian) who are willing and able to provide informed consent or assent to take part, and who understand what the study involves.

Who may not be able to join:

• Females who are pregnant or breastfeeding.
• People who cannot have both nasal passages examined for any reason, including a significantly deviated nasal septum.
• People who cannot breathe through both sides of the nose.
• People who are currently using XHANCE® (the study drug).
• People who have previously used XHANCE for more than one month without achieving adequate symptom relief.
• People who have had nasal or sinus surgery within 6 months before screening, or who have not fully healed from previous nasal or sinus surgery.
• People with certain current sinus conditions, including tooth-related sinusitis, a sinus mucocele (a type of mucus-filled cyst), allergic fungal sinusitis, or complicated sinus disease that has spread beyond the sinuses.
• People who have a tumour in the sinuses or nasal passages.
• People who have nasal polyps of grade 1 or higher in either nostril, as found during the nasal camera exam at screening.
• People who have a hole in the nasal septum (nasal septum perforation).
• People who have had more than one nosebleed with significant bleeding in the month before screening.
• People who have signs of significant injury or ulceration inside the nose found at the screening nasal exam.
• People who currently have rebound nasal congestion caused by overuse of nasal decongestant sprays (rhinitis medicamentosa).
• People who have significant structural abnormalities of the mouth, such as a cleft palate.
• People who have a diagnosis of cystic fibrosis.
• People with a history of eosinophilic granulomatosis with polyangiitis (also known as Churg-Strauss syndrome), a condition affecting blood vessels.
• People who have an active nasal infection, acute sinusitis, upper respiratory infection, influenza, or COVID-19, or who have not yet finished their antibiotic course or fully recovered — though they may be able to be re-screened 4 weeks after recovery.
• People who are planning to have sinus or nasal surgery during the study period.
• People who have an allergy, sensitivity, or medical reason to avoid corticosteroids or steroids.
• People who have previously used oral steroids for their sinus condition without any symptom relief.
• People who have a steroid-releasing sinus stent still in place within 30 days of the screening visit.
• People who have an allergy or sensitivity to any ingredient in the study medication.
• People who have used systemic steroids (such as tablets or injections) within 1 month before screening, except where permitted for asthma or COPD as outlined in the inclusion criteria.
• People who currently have a fungal infection in the nose or mouth (oral or nasal candidiasis).
• People with a current or past diagnosis of glaucoma or raised eye pressure.
• People who have previously had raised eye pressure caused by any form of steroid treatment.
• People with a current or past diagnosis of cataracts in either eye, unless both natural eye lenses have been removed.
• People with a history or current condition of immune system weakness for any reason (including poor nutrition) that could affect how they respond to the treatment.
• People with any serious or unstable illness, psychiatric condition, or other significant health issue that, in the investigator's opinion, could affect the study results or the person's ability to participate.
• People with a positive drug test, or a history of drug or alcohol misuse or dependence, that in the investigator's opinion could affect participation in the study.
• People who have taken part in another clinical trial involving an investigational drug within 30 days of the screening visit.
• People who have received certain immune-modifying biologic medications — including mepolizumab, reslizumab, dupilumab, omalizumab, benralizumab, tezepelumab, or any similar monoclonal antibody — within 6 months of the screening visit.
• People who are currently taking certain strong medications that affect how the body processes drugs (strong CYP3A4 inhibitors), such as ritonavir, itraconazole, ketoconazole, clarithromycin, or similar medicines (confirm with trial site for the full list).
• People whose parent, guardian, or caregiver is an employee or family member of an employee at the study site or investigator's team directly involved in this study.
• People who report unexplained worsening of their vision in the past 3 months.

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