An observational study in Severe Asthma, sponsored by AstraZeneca. Completed at 24 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by AstraZeneca · Observational
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 291 is above the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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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.
Exclusion Criteria:
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
Time frame: 8 weeks
Changes from baseline in Asthma Control Questionnaire (ACQ-6)
The changes from baseline in Asthma Control Questionnaire (ACQ-6) score at 1, 2, 3, 4, 24, and 56 weeks of benralizumab treatment. Minimum Value - '0' Maximum Value - '6' The lower the value better is the outcome.
Time frame: 56 weeks
Percentage of patients with a total score improvement with regards to Minimal clinically important difference in ACQ-6 (Asthma controlled questionnaire)
Percentage of patients with a total score improvement of ≥ 0.5 points (minimal clinically important difference \[MCID\]) in ACQ-6 (Asthma controlled questionnaire) at 1, 2, 3, 4, 8, 24, and 56 weeks of receiving benralizumab compared to baseline Minimum Value - '0' Maximum Value - '6' The lower the value better is the outcome.
Time frame: 56 weeks
Percentage of patients based on their Asthma control using ACQ-6
Percentage of patients with well-controlled asthma (ACQ-6 ≤ 0.75), partly controlled asthma (ACQ-6 between \>0.75 and \<1.5), and uncontrolled asthma (ACQ-6 ≥ 1.5) at baseline and at 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab treatment Minimum Value - '0' Maximum Value - '6' The lower the value better is the outcome.
Time frame: 56 weeks
Patient global impression of change (PGI-C) response
The patient global impression of change (PGI-C) response at 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab treatment Minimum Value - '1' Maximum Value - '7' The lower the value better is the outcome
Time frame: 56 weeks
Patient global impression of severity (PGI-S) response
The patient global impression of severity (PGI-S) response at 0, 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab treatment Minimum Value - '1' Maximum Value - '6' The lower the value better is the outcome
Time frame: 56 weeks
Pre-bronchodilator forced expiratory volume in the first second (FEV1)
Changes in the Pre-bronchodilator forced expiratory volume in the first second (Pre BD - FEV1) Unit - "ml' It will measure the change value - The higher the better
Time frame: 56 weeks
Change from baseline of the patient-reported nasal polyposis symptoms
Change from baseline using the visual analog scale (VAS) for the following parameters 1. Loss of smell 2. Nasal blockage/nasal Congestion 3. Difficulty with sleeping due to nasal symptoms 4. Headache/Pressure on face Minimum Value - '1' Maximum Value - '10' The lower the value better is the outcome.
Time frame: 56 weeks
Pre-bronchodilator forced vital capacity (FVC) changes
Change in the pre-BD Forced vital capacity (FVC) changes Unit - "ml' It will measure the change value - The higher the better
Time frame: 56 weeks
Percentage of patients who achieved 100 ml improvement in their lung function
Percentage of patients who achieved 100 ml improvement in their lung function (Pre BD - FEV1) This will be measured as '%' More the value better is the outcome
Time frame: 56 Weeks
Plan to share: Yes — 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.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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