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

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

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.

Study Overview

• Status: Completed
• Conditions: Nasal Polyps; Severe Eosinophilic Asthma
• Intervention / Treatment: Other: FASENRA(benralizumab)

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.

• Study Type: Observational
• Enrollment (Actual): 273

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69317
    • Research Site
  • Marseille, France, 13015
    • Research Site
  • Montpellier, France, 34090
    • Research Site
  • Nantes, France
    • Research Site
  • Strasbourg, France
    • Research Site
• Germany
  • Lubeck, Germany
    • Research Site
  • Wiesbaden, Germany, 65183
    • Research Site
• Italy
  • Catania, Italy, 95123
    • Research Site
  • Catanzaro, Italy, 88100
    • Research Site
  • Firenze, Italy, 50134
    • Research Site
  • Milan, Italy, 20162
    • Research Site
  • Modena, Italy, 41124
    • Research Site
  • Monserrato, Italy, 09042
    • Research Site
  • Napoli, Italy, 80131
    • Research Site
  • Orbassano, Italy
    • Research Site
  • Ragusa, Italy, 97100
    • Research Site
  • Rome, Italy
    • Research Site
  • Rome, Italy, 00161
    • Research Site
  • Salerno, Italy, 84131
    • Research Site
  • Varese, Italy, 21100
    • Research Site
• Japan
  • Chuo-ku, Niigata-Shi, Japan
    • Research Site
  • Hiroshima-Shi, Japan
    • Research Site
  • Moriguchi-Shi, Japan
    • Research Site
  • Nagaoka-Shi, Japan
    • Research Site
  • Shinagawa-ku, Japan
    • Research Site
  • Yonago-Shi, Japan
    • Research Site
• Spain
  • A Coruna, Spain, 15006
    • Research Site
  • Alcorcon, Spain, 28922
    • Research Site
  • Barcelona, Spain
    • Research Site
  • Barcelona, Spain, 08003
    • Research Site
  • Cadiz, Spain, 11407
    • Research Site
  • Madrid, Spain
    • Research Site
  • Madrid, Spain, 28041
    • Research Site
  • Salamanca, Spain, 37007
    • Research Site
  • Sevilla, Spain, 41071
    • Research Site
  • Sevilla, Spain, 46017
    • Research Site
  • Valencia, Spain, 46015
    • Research Site
• United States
  • Colorado
    • Centennial, Colorado, United States, 80112
      • Research Site
    • Denver, Colorado, United States, 80206
      • Research Site
  • New York
    • Bronx, New York, United States, 10461
      • Research Site
    • Glendale, New York, United States, 11385
      • Research Site
    • New York, New York, United States, 10029
      • Research Site
    • Rochester, New York, United States, 14642
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Research Site
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population is SEA + NP patients on benralizumab.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

SEA+NP Patients on FASENRA (benralizumab)

Other: FASENRA(benralizumab); 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.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma medications	To describe asthma medications.	Up to 12 months from first benralizumab dose.
NP medications	To describe NP medications.	Up to 12 months from first benralizumab dose.
All-cause healthcare resource utilization	To describe all-cause healthcare resources utilization.	Up to 12 months from first benralizumab dose.
Asthma-related healthcare resources utilization	To describe asthma-related healthcare resources utilization.	Up to 12 months from first benralizumab dose.
NPS by subgroups	To describe the distribution (mean, median) of NPS among subgroups of patients with different characteristics: demographics, clinical characteristics, and asthma clinical outcomes (number of exacerbations). NPS is the the sum of left and 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 benzelizumab dose.
SNOT-22 total score by subgroups	To describe the distribution (mean, median) of SNOT-22 total scores among subgroups of patients with different characteristics : demographics, clinical characteristics, and asthma clinical outcomes (number of exacerbations). 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.

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Actual): October 28, 2022
• Study Completion (Actual): October 28, 2022

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Severe Eosinophilic Asthma, nasal polyps, benralizumab, FASENRA.
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Bronchial Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Leukocyte Disorders; Eosinophilia; Hypereosinophilic Syndrome; Asthma; Nasal Polyps; Polyps; Pulmonary Eosinophilia; Anti-Asthmatic Agents; Respiratory System Agents; Benralizumab
• Other Study ID Numbers: D3250R00099

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No