Clinical trial NCT05180357: RANS. Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps.
Official title: Retrospective, Observational Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps Treated by FASENRA®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Eosinophilic Asthma
Nasal Polyps
Keywords: Severe Eosinophilic Asthma, nasal polyps, benralizumab, FASENRA.
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-01-06
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is SEA + NP patients on benralizumab.

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.

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).

Primary outcomes:
measure: Baseline demographics, clinical characteristics, and background treatments, as well as PROs for asthma control and HRQoL, asthma exacerbation, and healthcare resource utilization.
timeFrame: At or up to 12 months prior to first benralizumab dose.
Secondary outcomes:
measure: Total NPS
timeFrame: Up to 12 months prior to and up to 12 months from first benralizumab dose.
measure: SNOT-22 total score
timeFrame: Up to 12 months prior to and up to 12 months from first benralizumab dose.
measure: Overall SCS use. SCS use for asthma only. SCS use for NP only
timeFrame: Up to 12 months from first benralizumab dose.
measure: Asthma Clinical outcomes.
timeFrame: Up to 12 months from first benralizumab dose.
measure: NP surgery type and/or procedure
timeFrame: Up to 12 months from first benralizumab dose.
measure: Repeated or revision surgery for NP
timeFrame: Up to 12 months from first benralizumab dose.
measure: Time to NP surgery
timeFrame: Up to 12 months from first benralizumab dose.
measure: NP surgery complications
timeFrame: Up to 12 months from first benralizumab dose.
Other outcomes:
measure: Asthma medications
timeFrame: Up to 12 months from first benralizumab dose.
measure: NP medications
timeFrame: Up to 12 months from first benralizumab dose.
measure: All-cause healthcare resource utilization
timeFrame: Up to 12 months from first benralizumab dose.
measure: Asthma-related healthcare resources utilization
timeFrame: Up to 12 months from first benralizumab dose.
measure: NPS by subgroups
timeFrame: Up to 12 months prior to and up to 12 months from first benzelizumab dose.
measure: SNOT-22 total score by subgroups
timeFrame: Up to 12 months prior to and up to 12 months from first benralizumab dose.
Locations:
city: Centennial
country: United States
facility: Research Site
state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Bronx
country: United States
facility: Research Site
state: New York
city: Glendale
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Lyon
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Lubeck
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Catanzaro
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Milan
country: Italy
facility: Research Site
city: Modena
country: Italy
facility: Research Site
city: Monserrato
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Orbassano
country: Italy
facility: Research Site
city: Ragusa
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
city: Salerno
country: Italy
facility: Research Site
city: Varese
country: Italy
facility: Research Site
city: Chuo-ku, Niigata-Shi
country: Japan
facility: Research Site
city: Hiroshima-Shi
country: Japan
facility: Research Site
city: Moriguchi-Shi
country: Japan
facility: Research Site
city: Nagaoka-Shi
country: Japan
facility: Research Site
city: Shinagawa-ku
country: Japan
facility: Research Site
city: Yonago-Shi
country: Japan
facility: Research Site
city: A Coruna
country: Spain
facility: Research Site
city: Alcorcon
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Cadiz
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
Study officials:
References: