NCT05603845

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 291 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Severe Asthma

Timeline

• Start date: 2023-02-20
• Primary completion: 2025-04-10
• Completion: 2025-04-10
• First posted: 2022-11-03
• Last updated: 2026-03-10

Locations

24 sites across 8 countries: Colombia, Dominican Republic, India, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates