NCT05603845Completed
Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients
Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients Multicountry, Multicenter, Observational, Prospective, Primary Data, Real-world Settings
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 291 (actual)
- First submitted
- 28 Oct 2022
- Start date
- Feb 2023
- Primary completion date
- Apr 2025
- Lead sponsor
- AstraZeneca
- Diseases
- Asthma
- NCT number
- NCT05603845
What you commit to
- Study type: Observational
- Participants enrolled: 291
- From Feb 2023 to the primary completion date, Apr 2025
- 24 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent biologics for asthma are not allowed. Acceptable wash-out periods for other asthma biologics: ≥30 days from the last dose of the previous biologic.
Other illness
- Clinically important pulmonary diseases other than asthma including chronic obstructive pulmonary disease (as the main diagnosis), bronchiectasis, idiopathic pulmonary fibrosis, pulmonary hypertension, alpha-1-antitrypsin-deficiency, and malignancy of any kind (NB: the following conditions are permitted: nasal polyposis, allergic rhinitis, atopic dermatitis, non-idiopathic pulmonary fibrosis).
- An acute or chronic condition that, in the investigator's opinion, would limit the patients' ability to complete questionnaires or participate in this study or impact the interpretations of results.
Other
- Currently enrolled in an interventional clinical study except patients being in parallel documented in a national asthma registry
- Women who are currently pregnant, breastfeeding, or lactating
Who the study is looking for
- Male or female patients aged 18 years or older with a physician's confirmed diagnosis of severe eosinophilic, uncontrolled asthma.
- Severe uncontrolled eosinophilic asthma requiring high-dose\* inhaled corticosteroid plus long-acting β adrenoceptor agonist as maintenance treatment.
- Patients who have been prescribed but not yet initiated treatment with benralizumab (Fasenra®) according to local approved prescribing information prior to signed informed consent.
- Provision of the signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation.
- Patients must be able and willing to read and comprehend written instructions and complete the paper PRO questionnaires required by the protocol.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.