RANS. Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps.

Study Overview
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Brief Summary
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The purpose of this observational study is to describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.

Detailed Description
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In light of the increasing importance of comorbidities in driving choice for biologics in severe asthma there is a knowledge gap to understand SEA patients with comorbid NP for whom the decision to start biologics was based on the presence of severe, uncontrolled asthma. This retrospective, observational study will describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.

Official Title
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Retrospective, Observational Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps Treated by FASENRA®

Conditions
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Severe Eosinophilic Asthma, Nasal Polyps

Intervention / Treatment
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* Other: FASENRA(benralizumab)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current or previous treatment with benralizumab for SEA Physician-confirmed diagnosis and evaluation of NP using NPS and/or SNOT-22 before and after first benralizumab injection Patients who have follow-up period of at least 5 months from first benralizumab injection or at least 4 consecutive injections of benralizumab Able to provide signed informed consent (if required based on local guidelines) Exclusion Criteria: Patient on any other biologic during the 12 months prior to treatment with benralizumab Previously or currently receiving any biologics for the treatment of asthma or NP in a clinical trial. This exclusion criteria does not apply to patients that received biologic treatment from openlabel one-arm interventional studies that provided biologic treatment as part of standard of care (according to approved labelling in that country).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SEA+NP Patients on FASENRA (benralizumab)<br>SEA+NP Patients on FASENRA (benralizumab) | Other: FASENRA(benralizumab)<br>* This is a retrospective, observational study with secondary data collection utilizing medical chart review in hospitals or clinical centres that treated SEA + NP patients with benralizumab. Patient data including demographics, clinical characteristics, medication history, biologic treatment, and NP and asthma clinical outcomes will be abstracted from patient medical charts onto a pre-approved electronic case report form. No personal identifiable data will be collected. Data from all participating centres will be combined into a single anonymised dataset for analysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline demographics, clinical characteristics, and background treatments, as well as PROs for asthma control and HRQoL, asthma exacerbation, and healthcare resource utilization. | To describe baseline demographics, clinical characteristics, and background treatments, as well as PROs (patient-reported outcomes) for asthma control and HRQoL(health-related quality of life), asthma exacerbation, and healthcare resource utilization. | At or up to 12 months prior to first benralizumab dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total NPS | To describe the distribution (mean, median, range) of NPS (nasal polyp score) before and after initiation of benralizumab among SEA (severe eosinophilic asthma) +NP (nasal polyps) patient. NPS is the sum of the left and the right nostril scores evaluated by nasal endoscopy. Total score ranges from 0 to 8, with higher scores indicate larger-sized polyps. | Up to 12 months prior to and up to 12 months from first benralizumab dose. | 
| SNOT-22 total score | To describe the distribution (mean, median, range) of NP patient reported HRQoL total score (SNOT-22[Sino-nasal Outcome Test-22]) before and after initiation of benralizumab among EA+NP patients. SNOT-22 measures physical problems, functional limitations, and emotional consequences of sino-nasal conditions. SNOT-22 total score is calculated as the sum of all 22 responses and range from 0 to 110 (higher scores indicate poorer HRQoL). | Up to 12 months prior to and up to 12 months from first benralizumab dose. | 
| Overall SCS use. SCS use for asthma only. SCS use for NP only | To describe the use of SCS (systemic corticosteroids) after initiation of benralizumab among SEA + NP patients | Up to 12 months from first benralizumab dose. | 
| Asthma Clinical outcomes. | To describe asthma exacerbations, PROs, lung function, and benralizumab treatment patterns. | Up to 12 months from first benralizumab dose. | 
| NP surgery type and/or procedure | Proportion of patients with different type of surgery and/or procedure | Up to 12 months from first benralizumab dose. | 
| Repeated or revision surgery for NP | Proportion of patients with repeated or revision surgery | Up to 12 months from first benralizumab dose. | 
| Time to NP surgery | Timing (in days) from first benralizumab dose to NP surgery and/or repeated/revision surgery | Up to 12 months from first benralizumab dose. | 
| NP surgery complications | Proportion of patients with minor and major surgical complication. | Up to 12 months from first benralizumab dose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Eosinophilic Asthma, nasal polyps, benralizumab, FASENRA.