BRazilian Asthmatics patients EOSinophilic profile (BRAEOS) - BRAEOS

Study identifier:D3250R00045

ClinicalTrials.gov identifier:NCT03925415

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Severe Asthma

Phase

N/A

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

414

Study type

Observational

Age

N/A

Date

Study Start Date: 24 Jan 2019

Primary Completion Date: 15 Oct 2019

Study Completion Date: 15 Oct 2019

Study design

Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Aug 2020 by AstraZeneca

Collaborators

Medical Writer: Dr. Rodrigo Athanazio, CRO: CTI-Eurotrials

Inclusion and exclusion criteria

Inclusion Criteria

- Male or female subject, aged 18 years or older at the time of study entry.
- Subject followed at a participating centre and attending a routine clinical appointment.
- Subjects with evidence of asthma of either:
o Documented airway reversibility (forced expiratory volume in one second (FEV1) ≥12% and 200 mL) using the maximum post-bronchodilator procedure OR
o Documented airway hyperresponsiveness (provocative concentration of methacholine causing a ≥20% fall in FEV1) OR
o Documented airflow variability in FEV1 ≥20% between two consecutive lung function assessments prior to study entry (FEV1 values recorded during exacerbations should not be considered for this criterion)
- Subjects with a diagnosis of severe asthma for at least one year, according to the criteria of the International ERS/ATS Guidelines on Definition, Evaluation and Treatment of Severe Asthma (6), i.e.:
o Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5 asthma (high dose ICS (Appendix A) and LABA or leukotriene modifier/theophylline) for the previous year; or
o Systemic CS for ≥50% of the previous year to prevent it from becoming “uncontrolled” or which remains “uncontrolled” despite this therapy.
- Subject with accurate and complete medical records at the centre.
- Subject that voluntarily signed and dated the informed consent form prior to study entry.

Exclusion Criteria

- Subjects experiencing a moderate or severe asthma exacerbation as per the Official ATS/ERS Statement on Asthma Control (22) at the time of the study entry, or who had a moderate or severe asthma exacerbation less than 4 weeks prior to study entry.
- Subjects whose pharmacological therapy for asthma was modified in the 3 months prior to study entry.
- Subjects diagnosed with at least one of the following:
o Lung cancer
o Pulmonary fibrosis
o Allergic bronchopulmonary aspergillosis
o Eosinophilic granulomatosis with polyangiitis
o Clinically relevant bronchiectasis or bronchiectasis associated with cystic fibrosis and/or allergic bronchopulmonary aspergillosis.
o Chronic obstructive pulmonary disease associated with a smoking history ≥10 pack-years and/or history of exposure to biomass fuel combustion
- Subjects who are currently smokers or who have a history of smoking ≥ 10 pack-years.

No locations available

Arms	Assigned Interventions

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

Erica Ferreira

+55113737-4425