None listed
Conditions
Brief summary
The Australian Mepolizumab Registry for Chronic Rhinosinusitis with Nasal Polyps (AMR-CRSwNP) will be an electronic registry of well characterised patients with severe eosinophilic CRSwNP who receive mepolizumb treatment. It will be a national, multi-centre, observational post-marketing surveillance registry. Patients will receive mepolizumab via the Australian Commonwealth Government Pharmaceutical Benefits Scheme (PBS) or outside of the PBS restrictions. Patients will be identified for participation across multiple clinics in Australia. The central registry team will manage participant recruitment and data collection via a central telehealth model. Participants will be characterised at baseline (before starting mepolizumab) and have 12 months follow-up. The registry will provide insight into CRSwNP patient characteristics , report on mepolizumab use (effectiveness, safety) and be a databank for future research.
Interventions
Observational post-marketing surveillance registry of adults receiving mepolizumab treatment for severe eosinophilic chronic rhinosinusitis with nasal polyps.
Participants will participate in 2 structured computer-assisted telephone interviews with a member of the research team, and complete post-interview questionnaires. These are completed at baseline (prior to commencement of mepolizumab treatment) and again 12 months after mepolizumab commencement. Completion of each interview and the que
Observational post-marketing surveillance registry of adults receiving mepolizumab treatment for severe eosinophilic chronic rhinosinusitis with nasal polyps. Participants will participate in 2 structured computer-assisted telephone interviews with a member of the research team, and complete post-interview questionnaires. These are completed at baseline (prior to commencement of mepolizumab treatment) and again 12 months after mepolizumab commencement. Completion of each interview and the questionnaires will take approximately 2 hours. Data from the participants' medical records are also collected for the baseline and 12 month followup assessments (including nasal polyp scores, sinus surgery details). The participants' response to mepolizumab treatment will be observed (rhinosinusitis/nasal polyps symptoms, requirement for sinus surgery, health-related quality of life, requirement for systemic corticosteroid treatment, adverse drug-related effects, asthma symptom control for participants with asthma diagnosis)
Sponsors
The University of Newcastle
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants will have a confirmed diagnosis of severe CRSwNP with eosinophilic inflammation. They will be eligible for assessment for commencement of Pharmaceutical Benefits Scheme (PBS)-subsidised mepolizumab per below criteria #3-7 (OR eligible to commence mepolizumab for CRSwNP outside of the PBS restrictions) 1. Able to provide informed consent 2. Age greater than or equal to 18 years 3. Diagnosis of CRSwNP confirmed by direct nasal examination (OR diagnosis from at least 2 physicians/ENTs experienced in management of CRSwNP) 4. Peripheral blood eosinophil (PBE) count of greater than or equal to 300 cells/µL 5. Adherence to intranasal corticosteroid therapy for at least 2 months (unless contraindicated or not tolerated) 6. Previous nasal polyps surgery; OR details of surgical exception 7. At least 2 of the following: -Baseline bilateral nasal polyp (NP) score of greater than or equal to 5 (out of maximum score of 8, with minimum score of 2 in each nasal cavity) -Baseline nasal obstruction visual analogue score (VAS) of > 5 (out of 10) -Baseline overall symptom visual analogue score (VAS) of > 7 (out of 10) 8. Able to access a telephone and/or computer with internet
Exclusion criteria
1. People highly dependent on medical care 2. Cognitive impairment preventing data collection
Outcome results
None listed