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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

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

External Links

•   CSR Synopsis