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Completed

NCT Number: NCT05180357

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

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.

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Key information

Conditions

Severe Eosinophilic Asthma Eosinophilia Hematologic Diseases Hemic and Lymphatic Diseases Hypereosinophilic Syndrome Leukocyte Disorders Lung Diseases Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Pulmonary Eosinophilia Respiratory Tract Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Lyon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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).

Treatment and study plan

FASENRA(benralizumab)

Other

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.

Primary outcomes

  1. Baseline demographics, clinical characteristics, and background treatments, as well as PROs for asthma control and HRQoL, asthma exacerbation, and healthcare resource utilization.

    Time frame: 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 outcomes

  1. Total NPS

    Time frame: 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.

  2. SNOT-22 total score

    Time frame: 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).

  3. Overall SCS use. SCS use for asthma only. SCS use for NP only

    Time frame: Up to 12 months from first benralizumab dose.

    To describe the use of SCS (systemic corticosteroids) after initiation of benralizumab among SEA + NP patients

  4. Asthma Clinical outcomes.

    Time frame: Up to 12 months from first benralizumab dose.

    To describe asthma exacerbations, PROs, lung function, and benralizumab treatment patterns.

  5. NP surgery type and/or procedure

    Time frame: Up to 12 months from first benralizumab dose.

    Proportion of patients with different type of surgery and/or procedure

  6. Repeated or revision surgery for NP

    Time frame: Up to 12 months from first benralizumab dose.

    Proportion of patients with repeated or revision surgery

  7. Time to NP surgery

    Time frame: Up to 12 months from first benralizumab dose.

    Timing (in days) from first benralizumab dose to NP surgery and/or repeated/revision surgery

  8. NP surgery complications

    Time frame: Up to 12 months from first benralizumab dose.

    Proportion of patients with minor and major surgical complication.

Other outcomes

  1. Asthma medications

    Time frame: Up to 12 months from first benralizumab dose.

    To describe asthma medications.

  2. NP medications

    Time frame: Up to 12 months from first benralizumab dose.

    To describe NP medications.

  3. All-cause healthcare resource utilization

    Time frame: Up to 12 months from first benralizumab dose.

    To describe all-cause healthcare resources utilization.

  4. Asthma-related healthcare resources utilization

    Time frame: Up to 12 months from first benralizumab dose.

    To describe asthma-related healthcare resources utilization.

  5. NPS by subgroups

    Time frame: Up to 12 months prior to and up to 12 months from first benzelizumab dose.

    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.

  6. SNOT-22 total score by subgroups

    Time frame: Up to 12 months prior to and up to 12 months from first benralizumab dose.

    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).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: RANS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2022
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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