Prevalence of the Eosinophilic Phenotype Among Severe Asthma Patients

NCT ID: NCT03931954

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

794 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-15

Study Completion Date

2020-11-26

Brief Summary

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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

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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.

Conditions

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Severe Asthma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Study population

Patients completing the inclusión criteria

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maarten beekman, MD

Role: STUDY_CHAIR

medical lead respiratory International

Monica Olmos, MD

Role: STUDY_CHAIR

Study delivery lead

Locations

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Research Site

Buenos Aires, , Argentina

Site Status

Research Site

Rosario, , Argentina

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Research Site

Curicó, , Chile

Site Status

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Santiago, , Chile

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Barranquilla, , Colombia

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Bogotá, , Colombia

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Bucaramanga, , Colombia

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Pereira, , Colombia

Site Status

Research Site

San José, , Costa Rica

Site Status

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Guadalajara, , Mexico

Site Status

Research Site

Mérida, , Mexico

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Puebla City, , Mexico

Site Status

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San Juan del Río, , Mexico

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Villahermosa, , Mexico

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Dammam, , Saudi Arabia

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Research Site

Jeddah, , Saudi Arabia

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Research Site

Riyadh, , Saudi Arabia

Site Status

Research Site

Riyadh, , Saudi Arabia

Site Status

Countries

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Argentina Chile Colombia Costa Rica Mexico Saudi Arabia

References

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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.

Reference Type DERIVED
PMID: 35177038 (View on PubMed)

Other Identifiers

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D2287R00140

Identifier Type: -

Identifier Source: org_study_id

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