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

AstraZeneca

Status: Completed

Conditions: Severe Eosinophilic Asthma; Nasal Polyps

Treatments: Other: FASENRA(benralizumab)

Study type: Observational

Funder types: Industry

Identifiers

NCT05180357

D3250R00099

Details and patient eligibility

About

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.

Full 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.

Enrollment: 273 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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).

Trial design

273 participants in 1 patient group

SEA+NP Patients on FASENRA (benralizumab)

Description:

SEA+NP Patients on FASENRA (benralizumab)

Treatment:

Other: FASENRA(benralizumab)