BRazilian Asthmatics Patients EOSinophilic Profile (BRAEOS)

NCT03925415 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 414

Last updated 2020-08-14

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Medical Writer: Dr. Rodrigo Athanazio

    collaborator UNKNOWN
  • CRO: CTI-Eurotrials

    collaborator UNKNOWN
  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Adelmir Machado, MD · Associação PROAR - Associação do Programa de Controle da Asma e da Rinite Alérgica na Bahia

  • Faradiba Serpa, MD · Santa Casa de Misericórdia de Vitória

  • Marcelo Rabahi, MD · CLARE - CLINICA DE PNEUMOLOGIA S/S

  • Daniela Blanco, MD · Hospital São Lucas da PUCRS

  • Marina Lima, MD · Hospital DIA do Pulmão / Complexo de Prevenção, Diagnóstico, Terapia e Reabilitação Respiratória LTDA

  • Rafael Stelmach, MD · InCor - Instituto do Coração - HCFMUSP.

  • Pedro Francisco Giovina-Bianchi Júnior, MD · HCUSP - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

  • Alcindo Cerci Neto, MD · Universidade Estadual de Londrina

  • Martti Antila, MD · Clínica de Alergia Martti Antila / CMPC Pesquisa Clínica

  • Luisa Karla Arruda, MD · HCUSP RP - Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-24
Primary Completion
2019-10-15
Completion
2019-10-15

Countries

  • Brazil

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03925415 on ClinicalTrials.gov