Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients
iOUTRUN
1 other identifier
observational
291
8 countries
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
Typical duration for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2022
CompletedFirst Posted
Study publicly available on registry
November 3, 2022
CompletedStudy Start
First participant enrolled
February 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2025
CompletedMarch 10, 2026
March 1, 2026
2.1 years
October 28, 2022
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes from baseline in Asthma Control Questionnaire (ACQ-6)
The changes from baseline in Asthma Control Questionnaire (ACQ-6) score at eight weeks of benralizumab treatment. Minimum Value - '0' Maximum Value - '6' The lower the value better is the outcome
8 weeks
Secondary Outcomes (9)
Changes from baseline in Asthma Control Questionnaire (ACQ-6)
56 weeks
Percentage of patients with a total score improvement with regards to Minimal clinically important difference in ACQ-6 (Asthma controlled questionnaire)
56 weeks
Percentage of patients based on their Asthma control using ACQ-6
56 weeks
Patient global impression of change (PGI-C) response
56 weeks
Patient global impression of severity (PGI-S) response
56 weeks
- +4 more secondary outcomes
Eligibility Criteria
The study will recruit 410 adult patients with confirmed severe eosinophilic asthma who meet all inclusion criteria and none of the exclusion criteria in 9 countries as described above. Approximately 6-8 hospitals per country will participate in the study which have previous experience with biologic treatment, can initiate treatment with benralizumab, and have a good oversight on the severe asthma population.
You may qualify if:
- 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.
You may not qualify if:
- 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).
- Currently enrolled in an interventional clinical study except patients being in parallel documented in a national asthma registry
- 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.
- 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.
- Women who are currently pregnant, breastfeeding, or lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (24)
Research Site
Bogotá, Colombia
Research Site
Bucaramanga, Colombia
Research Site
Ibagué, Colombia
Research Site
Pereira, Colombia
Research Site
Santiago de los Caballeros, Dominican Republic
Research Site
Santo Domingo, Dominican Republic
Research Site
Ahmedabad, India
Research Site
Ajmer, India
Research Site
Chennai, India
Research Site
Delhi, India
Research Site
Hyderabad, India
Research Site
Jaipur, India
Research Site
Kolkata, India
Research Site
Pune, India
Research Site
Secundrabad, India
Research Site
Vadodara, India
Research Site
Sabah Al Salem, Kuwait
Research Site
Muscat, Oman
Research Site
Doha, Qatar
Research Site
Jeddah, Saudi Arabia
Research Site
Riyadh, Saudi Arabia
Research Site
Abu Dhabi, United Arab Emirates
Research Site
Al Ain City, United Arab Emirates
Research Site
Dubai, United Arab Emirates
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2022
First Posted
November 3, 2022
Study Start
February 20, 2023
Primary Completion
April 10, 2025
Study Completion
April 10, 2025
Last Updated
March 10, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.