Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients

Last updated: February 24, 2025
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Asthma

Lung Disease

Treatment

N/A

Clinical Study ID

NCT05603845
D3250R00113
  • Ages > 18
  • All Genders

Study Summary

This study aims to generate real-world data on the characteristics of patients receiving benralizumab to assess early PRO parameters as well as long-term treatment effects in the Gulf cooperative council (Kingdom of Saudi Arabia, Kuwait, United Arab Emirates, Oman, and Qatar), Latin America (Brazil, Argentina, and Colombia), and India. It is anticipated that the data generated will provide practical, patient-focused real-world evidence and enhance communications between patients and physicians in an objective and structured manner to ensure better disease control in patients under benralizumab treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female patients aged 18 years or older with a physician's confirmeddiagnosis of severe eosinophilic, uncontrolled asthma.

  2. Severe uncontrolled eosinophilic asthma requiring high-dose* inhaled corticosteroidplus long-acting β adrenoceptor agonist as maintenance treatment.

  3. Patients who have been prescribed but not yet initiated treatment with benralizumab (Fasenra®) according to local approved prescribing information prior to signedinformed consent.

  4. Provision of the signed written informed consent form (ICF) indicating that theyunderstand the purpose of the study and procedures required for participation.

  5. Patients must be able and willing to read and comprehend written instructions andcomplete the paper PRO questionnaires required by the protocol.

Exclusion

Exclusion Criteria:

  1. Clinically important pulmonary diseases other than asthma including chronicobstructive pulmonary disease (as the main diagnosis), bronchiectasis, idiopathicpulmonary fibrosis, pulmonary hypertension, alpha-1-antitrypsin-deficiency, andmalignancy of any kind (NB: the following conditions are permitted: nasal polyposis,allergic rhinitis, atopic dermatitis, non-idiopathic pulmonary fibrosis).

  2. Currently enrolled in an interventional clinical study except patients being inparallel documented in a national asthma registry

  3. An acute or chronic condition that, in the investigator's opinion, would limit thepatients' ability to complete questionnaires or participate in this study or impactthe interpretations of results.

  4. Concurrent biologics for asthma are not allowed. Acceptable wash-out periods forother asthma biologics: ≥30 days from the last dose of the previous biologic.

  5. Women who are currently pregnant, breastfeeding, or lactating

Study Design

Total Participants: 291
Study Start date:
February 20, 2023
Estimated Completion Date:
April 07, 2025

Study Description

This is a multi-country, multi-center, observational, prospective study involving primary data collection within real-world pulmonary care settings for patients who receive benralizumab treatment for severe uncontrolled eosinophilic asthma.The decision by the physician to start benralizumab is made independently from study inclusion and patient informed consent. Patients will receive benralizumab injections according to the local label in the participating countries (Brazil, Argentina, Colombia, India, and the Gulf cooperative council, including the Kingdom of Saudi Arabia, United Arab Emirates, Kuwait, Oman, and Qatar). No study drug will be provided as part of the study. The entire study period duration will be 56 weeks for each subject. The study is anticipated to run for approximately 18 months and is not anticipated to exceed 24 months. A database soft lock is planned at the end of the initial 8-week period of the study, and one combined descriptive and analytical interim analysis will be performed when 50% of the enrolled subjects complete the 8-week follow-up.

Connect with a study center

  • Research Site

    São Paulo, Sao Paulo 05403-000
    Brazil

    Site Not Available

  • Research Site

    Medellin, Antioquia 50621
    Colombia

    Site Not Available

  • Research Site

    Soledad, Atlantico 83001
    Colombia

    Site Not Available

  • Research Site

    Bogota, Capital District 110111
    Colombia

    Site Not Available

  • Research Site

    Pereira, Risaralda 660001
    Colombia

    Site Not Available

  • Research Site

    Floridablanca, Santander 681004
    Colombia

    Site Not Available

  • Research Site

    Ibague, Tolima 730006
    Colombia

    Site Not Available

  • Research Site

    Cali, 760042
    Colombia

    Site Not Available

  • Research Site

    Ensanche la Fe, Santo Domingo 10514
    Dominican Republic

    Site Not Available

  • Research Site

    Santiago de los Caballeros, 51000
    Dominican Republic

    Site Not Available

  • Research Site

    Vadodara, Gujarat 390007
    India

    Site Not Available

  • Research Site

    Chennai, Tamil Nadu 600078
    India

    Site Not Available

  • Research Site

    Hyderabad, Telanagana 500084
    India

    Site Not Available

  • Research Site

    Shamiya, Shamiya-Kuwait 8VGW+6RW
    Kuwait

    Site Not Available

  • Research Site

    Doha,
    Qatar

    Site Not Available

  • Research Site

    Riyadh, Central 11211
    Saudi Arabia

    Site Not Available

  • Research Site

    Jeddah, 23431
    Saudi Arabia

    Site Not Available

  • King fahad medical city

    Riyadh, 11525
    Saudi Arabia

    Active - Recruiting

  • Research Site

    Abu Dhabi,
    United Arab Emirates

    Site Not Available

  • Research Site

    Jeddah, 23214
    United Arab Emirates

    Site Not Available

  • Research Site

    Riyadh,
    United Arab Emirates

    Site Not Available

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