Clinical trial NCT03931954: Prevalence of the Eosinophilic Phenotype Among Severe Asthma Patients
Official title: PREPARE STUDY: PRevalence of the Eosinophilic Phenotype Among SeveRE Asthma Patients in AstraZeneca International Region. A Multinational, Cross-Sectional, Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Asthma
Keywords: eosinophilic asthma
severe asthma
prevalence
phenotype
atopic phenotype
eosinophilic phenotype
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-04-30
Enrollment: 794
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Eosinophil count
timeFrame: There is only one study visit. During that study visit the sample will be collected
measure: Total serum IgE
timeFrame: There is only one study visit. during that visit the sample will be collected
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Curico
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Barranquilla
country: Colombia
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Bucaramanga
country: Colombia
facility: Research Site
city: Pereira
country: Colombia
facility: Research Site
city: San Jose
country: Costa Rica
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Merida
country: Mexico
facility: Research Site
city: Puebla
country: Mexico
facility: Research Site
city: San Juan Del Rio
country: Mexico
facility: Research Site
city: Villahermosa
country: Mexico
facility: Research Site
city: Dammam
country: Saudi Arabia
facility: Research Site
city: Jeddah
country: Saudi Arabia
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
Study officials:
affiliation: medical lead respiratory International
name: Maarten beekman, MD
role: STUDY_CHAIR
affiliation: Study delivery lead
name: Monica Olmos, MD
role: STUDY_CHAIR
References:
citation: 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.