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Completed

NCT Number: NCT04126499

Study to Characterise Patients Receiving Benralizumab in the Framework of an Individualized Access Program in Spain

Observational, retrospective study in adults (≥18 years) with severe asthma (maintenance treatment with high dose inhaled corticosteroids combined with long-acting agonist β2) and eosinophilic phenotype, who at the discretion of the investigator were candidates to receive benralizumab in the individualized access program approved by national health authorities.

Primary Objective: To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma who participated in the individualized access program approved in Spain and received at least one dose of benralizumab.

Secondary Objectives: To describe clinical outcomes in severe eosinophilic asthma patients who received at least three doses of benralizumab in the individualized access program.

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Key information

Conditions

Severe Eosinophilic Asthma Eosinophilia Hematologic Diseases Hemic and Lymphatic Diseases Hypereosinophilic Syndrome Leukocyte Disorders Lung Diseases Pulmonary Eosinophilia Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

BIG PAC

Madrid, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (age ≥18 years)
  • Diagnosis of severe eosinophilic asthma requiring stable treatment of high doses of inhaled corticosteroids and a long-acting agonist β2 ± additional asthma controller
  • Received at least one dose of benralizumab during the individualized access program period (March-December of 2018)
  • Informed consent signed

Exclusion criteria

  • Patients enrolled in a clinical trial who received benralizumab during the same period of the individualized access program
  • Refuse to sign the informed consent

Treatment and study plan

Primary outcomes

  1. Age

    Time frame: Up to 32 weeks

    Age (years)

  2. Sex

    Time frame: Up to 32 weeks

    Male, Female

  3. Body Mass Index (BMI)

    Time frame: Up to 32 weeks

    Weight and height will be combined to report BMI in kg/m^2

  4. Smoking status

    Time frame: Up to 32 weeks

    Current smoker, Ex-smoker, Never smoker

  5. Age at onset of asthma diagnosis

    Time frame: Up to 32 weeks

    Age (years)

  6. Comorbidities

    Time frame: Up to 32 weeks

    Multiple response (binomial): allergies, nasal polyposis, rhinitis, GERD, atopic dermatitis, condition related with chronic OCS use, other eosinophilic driven diseases

  7. Severe exacerbations

    Time frame: Up to 32 weeks

    Severe exacerbations in past 12 months: number and severity

  8. Emergency room (ER) visits

    Time frame: Up to 32 weeks

    Number of ER visits

  9. Hospitalizations

    Time frame: Up to 32 weeks

    Number of hospitalizations

  10. Unscheduled visits

    Time frame: Up to 32 weeks

    Number of unscheduled visits

  11. ACT

    Time frame: Up to 32 weeks

    ACT questionnaire score

  12. miniAQLQ

    Time frame: Up to 32 weeks

    miniAQLQ questionnaire score

  13. Blood eosinophils

    Time frame: Up to 32 weeks

    Blood eosinophils count (cells/microL)

Secondary outcomes

  1. Incidence of severe exacerbations

    Time frame: Up to 32 weeks

    The incidence rate for any severe exacerbations in each calendar year will be calculated as follows: the sum of any severe exacerbations in that year divided by the total duration of follow-up in the same calendar year.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Observational Retrospective Study to Characterise Patients Receiving Benralizumab in the Framework of an Individualized Access Program in Spain

Acronym: ORBE

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 15, 2019
Registry last updated
Jun 29, 2021

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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