RANS. Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps.
- Conditions
- Severe Eosinophilic AsthmaNasal Polyps
- Interventions
- Other: FASENRA(benralizumab)
- Registration Number
- NCT05180357
- Lead Sponsor
- AstraZeneca
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 273
- 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)
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SEA+NP Patients on FASENRA (benralizumab) FASENRA(benralizumab) SEA+NP Patients on FASENRA (benralizumab)
- Primary Outcome Measures
Name Time Method Baseline demographics, clinical characteristics, and background treatments, as well as PROs for asthma control and HRQoL, asthma exacerbation, and healthcare resource utilization. At or up to 12 months prior to first benralizumab dose. 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.
- Secondary Outcome Measures
Name Time Method Total NPS Up to 12 months prior to and up to 12 months from first benralizumab dose. 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.
SNOT-22 total score Up to 12 months prior to and up to 12 months from first benralizumab dose. 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).
Overall SCS use. SCS use for asthma only. SCS use for NP only Up to 12 months from first benralizumab dose. To describe the use of SCS (systemic corticosteroids) after initiation of benralizumab among SEA + NP patients
Asthma Clinical outcomes. Up to 12 months from first benralizumab dose. To describe asthma exacerbations, PROs, lung function, and benralizumab treatment patterns.
NP surgery type and/or procedure Up to 12 months from first benralizumab dose. Proportion of patients with different type of surgery and/or procedure
Repeated or revision surgery for NP Up to 12 months from first benralizumab dose. Proportion of patients with repeated or revision surgery
Time to NP surgery Up to 12 months from first benralizumab dose. Timing (in days) from first benralizumab dose to NP surgery and/or repeated/revision surgery
NP surgery complications Up to 12 months from first benralizumab dose. Proportion of patients with minor and major surgical complication.
Trial Locations
- Locations (1)
Research Site
🇪🇸Valencia, Spain