NCT03925415

BRazilian Asthmatics Patients EOSinophilic Profile (BRAEOS)

A National, Observational, Cross-Sectional, Multicenter Study to Estimate the Prevalence of an Eosinophilic Phenotype Among Severe Asthma Patients in Brazil

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 414 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Asthma is a complex and heterogeneous disease. Severe asthma is recognised as a major unmet need that poses a great burden on the healthcare system. While accounting for only a small proportion of the total asthmatic population, asthma-related costs are 1.7 to 4-fold higher than those observed in the mild-persistent asthma population and the associated personal and societal impact is significant. Severe asthma is not considered to be a single disease, but can be divided into several phenotypes, owing to the variety of inflammatory, clinical and functional characteristics that it can present with. One of the proposed and most studied phenotypes is severe eosinophilic asthma. Patients with severe asthma that is accompanied with a high concentration of eosinophils require greater healthcare resource use, overall greater disease management costs and have a much more impaired QoL than those who do not present with raised eosinophilia. While the number of targeted treatments for asthma management has been growing in recent years, the heterogeneity of clinical presentations, treatment responses and inflammatory processes involved represents an added challenge for health care professionals. Thus, severe asthma management is a complex endeavour and a thorough and up to date understanding of the pathophysiologic characteristics of the patient population promotes effective therapeutic decision-making. The purpose of this observational, cross-sectional, multicentre study is to determine the prevalence of an eosinophilic phenotype of blood eosinophil count \> 300 cells/mm3 among severe asthma patients followed at Brazilian sites specialized in the management of severe asthma. The prevalence of an atopic phenotype, asthma control, QoL and burden of disease will also be studied.

Detailed description

Knowledge of the prevalence of eosinophilia among adult, severe asthma patients in Brazil is limited. Moreover, data on the prevalence of an atopic phenotype within the adult, severe asthma population is scarce. Severe asthma management is a complex endeavour and a thorough and up to date understanding of the pathophysiologic characteristics of the patient population facilitates therapeutic decisions that effectively lead to disease control. The purpose of this observational, cross-sectional, multicentre study is to determine the prevalence of an eosinophilic phenotype of blood eosinophil count \> 300 cells/mm3 among severe asthma patients followed at Brazilian sites specialized in the management of severe asthma. The prevalence of an atopic phenotype, asthma control, QoL and burden of disease will also be studied. It is expected that this study will contribute to the understanding of severe asthma in Brazil, ultimately helping to inform therapeutic decisions and addressing patients' needs.

Conditions

• Severe Asthma

Timeline

• Start date: 2019-01-24
• Primary completion: 2019-10-15
• Completion: 2019-10-15
• First posted: 2019-04-24
• Last updated: 2020-08-14

Locations

6 sites across 1 country: Brazil