Phase 3 Chronic Rhinosinusitis Trial, Completed

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:

• Adults aged 18 years or older at the time of their first study visit.
• Women who could become pregnant must either be abstaining from sex, or using an effective form of birth control (such as the pill, contraceptive injections, a patch, an intrauterine device, a double-barrier method, or have a sterilised partner), or have had a surgical procedure that means they cannot become pregnant (such as a hysterectomy, removal of both ovaries, or tubal ligation), or have gone through menopause (no period for at least one year).
• Women who could become pregnant must have a negative urine pregnancy test at the first study visit.
• People with a history of chronic sinusitis who are currently experiencing at least 2 of the following symptoms — and at least one of those symptoms must be nasal congestion or nasal discharge — for 12 weeks or longer: nasal congestion, nasal discharge (from the front or back of the nose), facial pain or pressure, or reduced or lost sense of smell.
• People whose nasal lining shows signs of disease (such as swelling or infected discharge) on examination, or who have very small polyps (smaller than Grade 1) in the middle part of both nasal passages.
• People whose CT scan confirms sinus disease on both sides, with at least one sinus on each side showing a Lund-Mackay score of 1 or higher (confirm with trial site).
• People whose CT scan shows at least 25% blockage in the ethmoid sinuses and at least 25% blockage in at least one maxillary sinus (the sinuses in the cheek area).
• People who have had at least moderate nasal congestion on average in the 7 days before their first study visit.
• People who record an average morning congestion score of at least 1.5 on a symptom scale diary over a 7-day period within the first 14 days of a run-in phase (confirm with trial site for scoring details).
• People who are able to correctly complete a daily symptom diary during the run-in phase.
• People with asthma or chronic obstructive pulmonary disease (COPD) whose condition has been stable — meaning no emergency visits, hospitalisations, or courses of steroid tablets or injections — for at least 3 months before the first visit, and who have been on a stable, low dose of inhaled steroids for at least 3 months with plans to continue.
• People with aspirin-sensitive respiratory disease who have already completed aspirin desensitisation and have been on daily aspirin therapy for at least 6 months before the first visit.
• People who are able to stop using steroid nasal sprays and inhaled steroids (beyond the permitted doses for asthma or COPD) from the time of the screening visit.
• People who are able to stop using nasal decongestants, oral decongestants, and antihistamines from the first study visit.
• People who are able to correctly use a specific type of nasal delivery device called an exhalation delivery system (EDS), demonstrated at the first visit.
• People who are able to give informed consent, meaning they understand what the study involves and are willing to take part.

Who may not be able to join:

• Women who are pregnant or breastfeeding.
• People who cannot have both nasal passages examined for any reason, including a severely deviated nasal septum.
• People who are unable to breathe through both sides of their nose.
• People who are currently using the medicine XHANCE®.
• People who have previously used XHANCE® for more than one month without experiencing adequate symptom relief.
• People whose nasal or sinus structure makes it impossible to accurately measure sinus volume on a CT scan.
• People who have had nasal or sinus surgery within 6 months before the first visit, or who have not fully healed from a previous nasal or sinus surgery.
• People who currently have an odontogenic sinusitis (sinus infection from a tooth), a sinus mucocele (a type of sinus blockage with specific structural changes), allergic fungal sinusitis, or complicated sinus disease that has spread beyond the sinuses or nasal cavity.
• People who have a tumour in the nose or sinuses.
• People who have nasal polyps of Grade 1 or higher (a free-floating polyp with a stalk) on either side of the nose, as seen on examination at screening.
• People who have a hole in their nasal septum (nasal septum perforation).
• People who have had more than one episode of significant nosebleed in the month before the first visit.
• People who show signs of significant tissue injury or ulceration (such as exposed cartilage) in the nose at the screening examination.
• 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 been diagnosed with cystic fibrosis.
• People with a history of Churg-Strauss syndrome or a condition affecting the movement of the tiny hairs (cilia) in the airways.
• People who have had a recent nasal or sinus infection, acute sinusitis, or upper respiratory tract infection that has not fully resolved, or whose symptoms resolved less than 4 weeks before the CT scan. These people may be able to reapply 4 weeks after full recovery.
• People who are planning to have nasal or sinus surgery during the study period.
• People who have an allergy, sensitivity, or medical reason preventing the use of corticosteroids or steroids.
• People who have previously taken oral steroids for chronic sinusitis and experienced no symptom relief.
• People who have a steroid-releasing sinus stent still in place within 30 days of the first visit.
• People who have an allergy or sensitivity to any of the inactive ingredients in the study medicine.
• People who have been exposed to systemic steroid treatments (such as steroid tablets, injections into a joint, or epidural steroids, or high-dose steroid creams) within one month before the first visit, except where permitted for those with asthma or COPD.
• People who currently have a fungal infection (candidiasis) in the nose.
• People who have ever been diagnosed with glaucoma or high pressure in the eyes, or who currently have either condition.
• People who have previously had increased eye pressure as a result of any steroid treatment.
• People who have ever been diagnosed with, or currently have, a specific type of eye lens problem called a subcapsular cataract in either eye.
• People who have a history of immune system deficiency.
• People who have any serious or unstable health condition, mental health condition, or other significant issue that, in the investigator's opinion, could affect the study results or the person's ability to participate.
• People who have a positive drug test, or a history of drug or alcohol misuse or dependence within the past year that, in the investigator's opinion, could affect participation.
• People who have taken part in another clinical drug trial within 30 days before the first visit.
• People who have received any of the following medicines within 6 months before the first visit: mepolizumab (Nucala®), reslizumab (Cinquair®), dupilumab (Dupixent®), omalizumab (Xolair®), or benralizumab (Fasenra™).
• People who are currently taking certain strong medicines that affect how the body processes drugs, known as strong CYP3A4 inhibitors — examples include ritonavir, ketoconazole, clarithromycin, and itraconazole (confirm the full list with the trial site).
• People who are employees of the investigating doctor or study centre, or are a family member of such an employee or the investigator.
• People who report an unexplained worsening of their vision in the past 3 months (such as difficulty reading or seeing road signs). Note: a diagnosis of age-related long-sightedness (presbyopia) confirmed by an eye care professional does not prevent participation.

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