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NCT03931954 Clinical Trial

Prevalence of the Eosinophilic Phenotype Among Severe Asthma Patients

Severe Asthma Clinical Trial

— PREPARE  

Official title:
PREPARE STUDY: PRevalence of the Eosinophilic Phenotype Among SeveRE Asthma Patients in AstraZeneca International Region. A Multinational, Cross-Sectional, Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03931954
Other study ID # D2287R00140
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 15, 2019
Est. completion date November 26, 2020

Study information
Verified date January 2021
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this cross-sectional, multicenter study is to determine the prevalence of an eosinophilic phenotype of blood eosinophil count ≥ 300 cells/mm3 among severe asthma patients who attend to sites specialized in the management of severe asthma in several countries in the AstraZeneca International Region. The prevalence of an atopic phenotype and asthma control, will also be studied.

Description:

To determine the prevalence of an eosinophilic phenotype of blood eosinophil count ≥ 300 cells/mm3 among severe asthma patients attending their routine clinical visit at sites specialized in the management of severe asthma in several countries in the AstraZeneca International Region. The prevalence of an atopic phenotype and the status of asthma control, will also be studied. It is expected that this study will contribute to the understanding of severe asthma, ultimately helping to inform therapeutic decisions and addressing patients' needs.

Recruitment information / eligibility
Status Completed
Enrollment 794
Est. completion date November 26, 2020
Est. primary completion date November 26, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria Patients must fulfil all of the following inclusion criteria to be included in the study: - Male or female patient, aged 12 years or older by the time of study entry - Patient visiting a participating center for a routine clinical appointment - Patient is willing and able to provide a blood sample for IgE and eosinophil levels determination as part of their routine clinical visit - Diagnosis of severe asthma for at least one year as defined by: - Treatment with guidelines-suggested medications for Global Initiative for Asthma (3) steps 4-5 asthma - Patients or their legal guardian, who voluntarily sign and date the informed consent form prior to study entry. Exclusion Criteria - Patients with a diagnosis of chronic obstructive pulmonary disease or other chronic respiratory condition beyond severe asthma - An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in this study Patients who are currently under a biologic therapy to treat their severe asthma

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Argentina Research Site Buenos Aires
Argentina Research Site Rosario
Chile Research Site Curico
Chile Research Site Santiago
Colombia Research Site Barranquilla
Colombia Research Site Bogota
Colombia Research Site Bucaramanga
Colombia Research Site Pereira
Costa Rica Research Site San Jose
Mexico Research Site Guadalajara
Mexico Research Site Merida
Mexico Research Site Puebla
Mexico Research Site San Juan Del Rio
Mexico Research Site Villahermosa
Saudi Arabia Research Site Dammam
Saudi Arabia Research Site Jeddah
Saudi Arabia Research Site Riyadh
Saudi Arabia Research Site Riyadh

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Argentina,  Chile,  Colombia,  Costa Rica,  Mexico,  Saudi Arabia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood Eosinophil count The level of eosinophils in the blood will be assessed from this blood sample and reported There is only one study visit. During that study visit the sample will be collected
Primary Total serum IgE Total serum IgE will be assessed from this blood sample and reported There is only one study visit. during that visit the sample will be collected
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