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:

• People aged 18 or older at the time of signing the consent form.
• People who weigh at least 40 kilograms (approximately 88 pounds).
• Both men and women are eligible, provided appropriate contraception is used where required.
• Women who are not pregnant or breastfeeding — either those who cannot become pregnant, or those who can become pregnant and are using a highly effective form of contraception (with a failure rate of less than 1% per year) during the study and for at least 105 days after the last dose. Women who can become pregnant must also have a negative pregnancy test within 24 hours before the first dose.
• People with a blood eosinophil count (a type of immune cell) above 2%, recorded either in the 12 months before the first study visit or confirmed by the time of the second visit. People with a count between 2% and 5% must also have asthma, or an intolerance to aspirin or similar anti-inflammatory medicines (confirm with trial site).
• People whose nasal polyps have been assessed by a doctor using a camera (endoscopy) and scored at least 5 out of 8, with at least 2 points in each nostril.
• People who have had at least one of the following: previous surgery to remove nasal polyps; use of steroid tablets or injections for at least 3 days in a row in the past 2 years to treat nasal polyps; or a medical reason why steroid medicines are not suitable or are not tolerated.
• People with severe nasal blockage, scoring more than 5 on a symptom scale (confirm with trial site for how this is measured).
• People who have had symptoms of chronic sinus inflammation (such as nasal blockage, nasal discharge, facial pressure or pain, and/or reduced or lost sense of smell) for at least 12 weeks before the first visit, with at least two symptoms present, one of which must be nasal blockage or nasal discharge.
• People who are able to understand and sign the consent form and follow the study requirements.

Who may not be able to join:

• People whom the treating doctor considers unfit for the study based on their medical history, physical examination, or test results — for example, those with a recent shingles episode or evidence of tuberculosis (active or hidden).
• People with cystic fibrosis.
• People with certain immune or structural conditions affecting the airways, including eosinophilic granulomatosis with polyangiitis (also known as Churg-Strauss syndrome), Young's syndrome, Kartagener's syndrome, or dyskinetic ciliary syndrome.
• People with a specific type of nasal polyp called antrochoanal polyps.
• People with a severely deviated nasal septum that prevents a full examination of both nostrils.
• People with an active sinus infection or upper respiratory tract infection at the time of screening, or within the 2 weeks before screening.
• People with ongoing medication-induced nasal congestion (sometimes called rebound rhinitis).
• People who have been admitted to hospital for an asthma attack within 4 weeks before screening.
• People who have had nasal or sinus surgery (such as polyp removal or balloon procedures) within 6 months before the first visit.
• People for whom nasal polyp surgery is considered medically unsuitable by the treating doctor.
• People with a known history of HIV infection.
• People with a known parasitic infection within 6 months before the first visit.
• People currently receiving or who have recently received chemotherapy, radiotherapy, or other investigational treatments within 3 months (or 5 half-lives of the treatment, whichever is longer) before the first dose.
• People with a known sensitivity to any of the study medications or their components, or a history of drug allergies that the investigator considers a concern (note: aspirin-sensitive participants may still be eligible — confirm with trial site).
• People with a history of allergic reaction to a type of medicine called an anti-IL-5 treatment or any other monoclonal antibody therapy.
• People who have taken part in a previous clinical trial of mepolizumab (the study drug).
• People currently using steroid nasal sprays or inhaled steroids administered through the nose who are not willing to continue using them in the same way throughout the study.
• People who have used steroid tablets, injections, or nasal drops (other than standard nasal sprays) within 4 weeks before screening, or who plan to use them during the main study period.
• People who have changed their steroid nasal spray or inhaled nasal steroid dose within 1 month before the first visit.
• People who have recently used certain biological or immune-suppressing treatments within a specified period before the first visit (confirm with trial site for specific timeframes).
• People who have used omalizumab (Xolair) within 130 days before the first visit.
• People who have started or changed the dose of a leukotriene-blocking medicine within 30 days before the first visit.
• People who have started or changed allergen immunotherapy (desensitisation treatment) within 3 months before the first visit.
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
• People who are unlikely to survive the full study period, have a rapidly worsening condition, or a life-threatening illness such as cancer. People with other conditions (such as neurological conditions) likely to affect breathing may also be excluded.
• People with serious, uncontrolled medical conditions affecting the hormonal, immune, heart, metabolic, nervous system, kidney, digestive, liver, or blood systems.
• People with symptoms suggesting an active COVID-19 infection (such as fever or cough).
• People who have had known contact with a confirmed COVID-19 case within the past 14 days, unless at least 14 days have passed since exposure and the person remains without symptoms.
• People with a known immune deficiency condition (other than one caused by corticosteroid use).
• People with a current cancer, or a history of cancer that has been in remission for less than 12 months before screening.
• People with active liver or bile duct disease (certain stable or minor liver conditions may be acceptable — confirm with trial site).
• People with specific abnormal liver blood test results above defined thresholds (confirm with trial site for exact values).
• People with unstable liver or bile duct disease showing signs such as fluid build-up in the abdomen, confusion, abnormal clotting, low protein levels, bleeding in the oesophagus or stomach, persistent jaundice, or cirrhosis.
• People with an abnormal heart rhythm measurement (QTcF) on an ECG above a defined threshold (confirm with trial site for exact values).
• People with a known or suspected history of alcohol or drug misuse within the 2 years before screening, where the investigator believes this would prevent the person from completing the study.
• People who are employed by or are immediate family members of anyone directly involved in running this study.
• People whom the investigator believes would be unable to read or complete the required study questionnaires.

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