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Prevalence of the Eosinophilic Phenotype Among Severe Asthma Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03931954
Acronym
PREPARE
Enrollment
794
Registered
2019-04-30
Start date
2019-05-15
Completion date
2020-11-26
Last updated
2021-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Asthma

Keywords

eosinophilic asthma, severe asthma, prevalence, phenotype, atopic phenotype, eosinophilic phenotype

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood Eosinophil countThere is only one study visit. During that study visit the sample will be collectedThe level of eosinophils in the blood will be assessed from this blood sample and reported
Total serum IgEThere is only one study visit. during that visit the sample will be collectedTotal serum IgE will be assessed from this blood sample and reported

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026