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.
Brief Title
RANS. Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Severe Eosinophilic Asthma
Nasal Polyps
Eligibility Criteria
Inclusion Criteria:
1. Current or previous treatment with benralizumab for SEA
2. Physician-confirmed diagnosis and evaluation of NP using NPS and/or SNOT-22 before and after first benralizumab injection
3. Patients who have follow-up period of at least 5 months from first benralizumab injection or at least 4 consecutive injections of benralizumab
4. Able to provide signed informed consent (if required based on local guidelines)
Exclusion Criteria:
1. Patient on any other biologic during the 12 months prior to treatment with benralizumab
2. 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).
1. Current or previous treatment with benralizumab for SEA
2. Physician-confirmed diagnosis and evaluation of NP using NPS and/or SNOT-22 before and after first benralizumab injection
3. Patients who have follow-up period of at least 5 months from first benralizumab injection or at least 4 consecutive injections of benralizumab
4. Able to provide signed informed consent (if required based on local guidelines)
Exclusion Criteria:
1. Patient on any other biologic during the 12 months prior to treatment with benralizumab
2. 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).
Inclusion Criteria
Inclusion Criteria:
1. Current or previous treatment with benralizumab for SEA
2. Physician-confirmed diagnosis and evaluation of NP using NPS and/or SNOT-22 before and after first benralizumab injection
3. Patients who have follow-up period of at least 5 months from first benralizumab injection or at least 4 consecutive injections of benralizumab
4. Able to provide signed informed consent (if required based on local guidelines)
1. Current or previous treatment with benralizumab for SEA
2. Physician-confirmed diagnosis and evaluation of NP using NPS and/or SNOT-22 before and after first benralizumab injection
3. Patients who have follow-up period of at least 5 months from first benralizumab injection or at least 4 consecutive injections of benralizumab
4. Able to provide signed informed consent (if required based on local guidelines)
Gender
All
Gender Based
false
Keywords
Severe Eosinophilic Asthma, nasal polyps, benralizumab, FASENRA.
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
99 Years
Minimum Age
18 Years
NCT Id
NCT05180357
Org Class
Industry
Org Full Name
AstraZeneca
Org Study Id
D3250R00099
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Retrospective, Observational Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps Treated by FASENRA®
Primary Outcomes
Outcome Description
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.
Outcome Measure
Baseline demographics, clinical characteristics, and background treatments, as well as PROs for asthma control and HRQoL, asthma exacerbation, and healthcare resource utilization.
Outcome Time Frame
At or up to 12 months prior to first benralizumab dose.
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Up to 12 months prior to and up to 12 months from first benralizumab dose.
Outcome Measure
Total NPS
Outcome Description
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).
Outcome Time Frame
Up to 12 months prior to and up to 12 months from first benralizumab dose.
Outcome Measure
SNOT-22 total score
Outcome Description
To describe the use of SCS (systemic corticosteroids) after initiation of benralizumab among SEA + NP patients
Outcome Time Frame
Up to 12 months from first benralizumab dose.
Outcome Measure
Overall SCS use. SCS use for asthma only. SCS use for NP only
Outcome Description
To describe asthma exacerbations, PROs, lung function, and benralizumab treatment patterns.
Outcome Time Frame
Up to 12 months from first benralizumab dose.
Outcome Measure
Asthma Clinical outcomes.
Outcome Description
Proportion of patients with different type of surgery and/or procedure
Outcome Time Frame
Up to 12 months from first benralizumab dose.
Outcome Measure
NP surgery type and/or procedure
Outcome Description
Proportion of patients with repeated or revision surgery
Outcome Time Frame
Up to 12 months from first benralizumab dose.
Outcome Measure
Repeated or revision surgery for NP
Outcome Description
Timing (in days) from first benralizumab dose to NP surgery and/or repeated/revision surgery
Outcome Time Frame
Up to 12 months from first benralizumab dose.
Outcome Measure
Time to NP surgery
Outcome Description
Proportion of patients with minor and major surgical complication.
Outcome Time Frame
Up to 12 months from first benralizumab dose.
Outcome Measure
NP surgery complications
See Also Links
Url
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
The study population is SEA + NP patients on benralizumab.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
99
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Golda Hudes
Investigator Email
ghudes@montefiore.org
Investigator Phone
646-229-9509