Prevalence of the Eosinophilic Phenotype Among Severe Asthma Patients

NCT03931954 | Completed

• 1 other identifier: D2287R00140
• Study Type: observational
• Target: 794
• Locations: 5 countries
• Sites: 14

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.

Conditions

Severe Asthma

Keywords

eosinophilic asthma; severe asthma; prevalence; phenotype; atopic phenotype; eosinophilic phenotype

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Study population

Patients completing the inclusión criteria

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (18)

Research Site

Buenos Aires, Argentina

Location

Research Site

Rosario, Argentina

Location

Research Site

Curicó, Chile

Location

Research Site

Santiago, Chile

Location

Research Site

Barranquilla, Colombia

Location

Research Site

Bogotá, Colombia

Location

Research Site

Bucaramanga, Colombia

Location

Research Site

Pereira, Colombia

Location

Research Site

San José, Costa Rica

Location

Research Site

Guadalajara, Mexico

Location

Research Site

Mérida, Mexico

Location

Research Site

Puebla City, Mexico

Location

Research Site

San Juan del Río, Mexico

Location

Research Site

Villahermosa, Mexico

Location

Research Site

Dammam, Saudi Arabia

Location

Research Site

Jeddah, Saudi Arabia

Location

Research Site

Riyadh, 111511, Saudi Arabia

Location

Research Site

Riyadh, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 35177038 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Asthma; Pulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Maarten beekman, MD

  medical lead respiratory International

  STUDY CHAIR

• Monica Olmos, MD

  Study delivery lead

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 30, 2019
• Study Start: May 15, 2019
• Primary Completion: November 26, 2020
• Study Completion: November 26, 2020
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

CO (1); ME (5); CL (2); SA (4); AR (2)