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OpenTrials
Completed

NCT Number: NCT04648839

Observational Retrospective Study on Clinical Outcomes of Patients Receiving Benralizumab in Spain.

Primary Objectives:

1. To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma in Spain who received at least one dose of Benralizumab, after its marketing authorization 2. To describe background treatment patterns of severe eosinophilic asthma patients at baseline and after the index date (benralizumab initiation)

This is a descriptive, observational, multi-centre, longitudinal, retrospective cohort study in adults patients (≥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 physician, received benralizumab accordingly to the clinical practice, in the period after the marketing authorization of benralizumab in Spain, on January 1st 2019.

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Key information

Conditions

Severe Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Madrid, 28041, 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.
  • Patients with at least 12-month data available before index date (starting benralizumab treatment)
  • Patients with at least 3-month electronic medical records data available from first benralizumab dose ("index date")
  • Informed consent signed.

Exclusion criteria

  • Patients who received benralizumab in a clinicaltrial, during the observation period.

Treatment and study plan

Primary outcomes

  1. Age

    Time frame: Up to 12 months (Baseline period)

    Specifically, at the time of taking the first dose of study drug

  2. Gender

    Time frame: Up to 12 months (Baseline period)

    Specifically, at the time of taking the first dose of study drug

  3. Smoking Habits

    Time frame: Up to 12 months (Baseline period)

  4. Age at athma diagnosis

    Time frame: Up to 12 months (Baseline period)

  5. Blood eosinophils count

    Time frame: Baseline period

  6. Total IgE

    Time frame: Baseline period

  7. Number of patients with positive Prick test

    Time frame: Baseline period

  8. FeNo

    Time frame: Baseline period

  9. Lung function (FEV1 and FVC)

    Time frame: Baseline period

  10. ACT (or ACQ) score

    Time frame: Baseline period

    Asthma Control Test (ACT), the scores range from 5 to 25, with higher scores reflecting greater asthma control.

    Asthma Control Questionnaire (ACQ), the total score range between 0 (well controlled asthma) and 6 (extremely poorly controlled)

  11. AQLQ score

    Time frame: Baseline period

    Asthma Quality of Life Questionnaire (AQLQ), it scores from 1 (minimum) to 7 (maximum) where the higher the score, the better the quality of life is

  12. Severe asthma exacerbations

    Time frame: In the previous 12 months

  13. Key comorbidities

    Time frame: Baseline period

  14. OCS-related comorbidities

    Time frame: Baseline period

  15. Concomitant asthma medications

    Time frame: Baseline period

  16. Physician office visits

    Time frame: Baseline period

    Split by primary care and specialist (asthma related)

  17. Emergency room visits

    Time frame: Baseline period

  18. Hospitalisations

    Time frame: Baseline period

    Number and duration

  19. Number of laboratory tests per patient

    Time frame: Baseline period

  20. Number of conventional radiology procedures per patient

    Time frame: Baseline period

  21. Number of diagnostic/therapeutic tests per patient

    Time frame: Baseline period

    Asthma related only

  22. Number of spirometries per patient

    Time frame: Baseline period

  23. Number of allergy tests per patient

    Time frame: Baseline period

  24. Number of computed axial tomographies per patient

    Time frame: Baseline period

  25. Number of magnetic resonance imaging procedures per patient

    Time frame: Baseline period

  26. Asthma treatment

    Time frame: Up to 24 months (study duration)

    Including previous biologic treatment, type of treatment and reasons for discontinuation or switching

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Observational Retrospective Study to Characterise and Assess Clinical Outcomes of Patients Receiving Benralizumab After Marketing Approval in Spain.

Acronym: ORBE-II

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2020
Registry last updated
Aug 19, 2022

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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