Australian Mepolizumab Registry for Chronic Rhinosinusitis with Nasal Polyps (AMR-CRSwNP)
- Conditions
- chronic rhinosinusitis with nasal polypsInflammatory and Immune System - Other inflammatory or immune system disordersRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12623000692639
- Lead Sponsor
- The University of Newcastle
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 140
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
1.People highly dependent on medical care
2.Cognitive impairment preventing data collection
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method