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Completed

NCT Number: NCT03931954

Prevalence of the Eosinophilic Phenotype Among Severe Asthma Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Blood Eosinophil count

    Time frame: There is only one study visit. During that study visit the sample will be collected

    The level of eosinophils in the blood will be assessed from this blood sample and reported

  2. Total serum IgE

    Time frame: There is only one study visit. during that visit the sample will be collected

    Total serum IgE will be assessed from this blood sample and reported

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: PREPARE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 30, 2019
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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