Prevalence of the Eosinophilic Phenotype Among Severe Asthma Patients (PREPARE)

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

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.

Study Overview

• Status: Completed
• Conditions: Severe Asthma

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.

• Study Type: Observational
• Enrollment (Actual): 794

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Research Site
  • Rosario, Argentina
    • Research Site
• Chile
  • Curico, Chile
    • Research Site
  • Santiago, Chile
    • Research Site
• Colombia
  • Barranquilla, Colombia
    • Research Site
  • Bogota, Colombia
    • Research Site
  • Bucaramanga, Colombia
    • Research Site
  • Pereira, Colombia
    • Research Site
• Costa Rica
  • San Jose, Costa Rica
    • Research Site
• Mexico
  • Guadalajara, Mexico
    • Research Site
  • Merida, Mexico
    • Research Site
  • Puebla, Mexico
    • Research Site
  • San Juan Del Rio, Mexico
    • Research Site
  • Villahermosa, Mexico
    • Research Site
• Saudi Arabia
  • Dammam, Saudi Arabia
    • Research Site
  • Jeddah, Saudi Arabia
    • Research Site
  • Riyadh, Saudi Arabia
    • Research Site
  • Riyadh, Saudi Arabia, 111511
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients from 12 years and older with severe asthma, as per the definition of the GINA 2018 Guidelines (GINA, 2018). Patients will be identified and invited to participate in the study consecutively, as they attend their routine clinical visit at the research centers.

To be included in the study, each patient should meet all the inclusion criteria and none of the exclusion criteria described in the sections below. Patients should provide written, informed consent prior to any study-specific procedures.

The enrolment period will be approximately 8 months or until the required number of patients has been included, whichever occurs first

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study population; Patients completing the inclusión criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Chair: Maarten beekman, MD, medical lead respiratory International; Study Chair: Monica Olmos, MD, Study delivery lead

Publications and helpful links

General Publications

• Al-Jahdali H, Wali S, Albanna AS, Allehebi R, Al-Matar H, Fattouh M, Beekman M. Prevalence of eosinophilic, atopic, and overlap phenotypes among patients with severe asthma in Saudi Arabia: a cross-sectional study. BMC Pulm Med. 2022 Feb 17;22(1):67. doi: 10.1186/s12890-022-01856-9.

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): November 26, 2020
• Study Completion (Actual): November 26, 2020

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: prevalence; phenotype; eosinophilic asthma; severe asthma; atopic phenotype; eosinophilic phenotype
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: D2287R00140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No