PROPE Severe Asthma Study in Egypt

NCT06283290 | Completed

• 1 other identifier: D3250R00122
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 4

Brief Summary

Asthma is a syndrome characterized by airway inflammation, reversible airway obstruction, and airway hyper-responsiveness. Patients present clinically with recurrent wheezing, shortness of breath, cough, and chest tightness. Asthma is a leading cause of morbidity with a global prevalence of approximately 300 million; it is estimated that the number of people with asthma may increase to 400 to 450 million people worldwide by 2025. Severe asthma is not considered a single disease; instead, it is divided into several phenotypes, owing to the variety of inflammatory, clinical, and functional characteristics that it can present with. One of the proposed and most studied phenotypes is severe eosinophilic asthma. Patients with severe asthma that is accompanied by a high concentration of eosinophils require greater healthcare resource use, greater disease management costs, and a much more impaired QoL than those who do not present with raised eosinophilia. While the number of targeted treatments for asthma management has been growing in recent years, the heterogeneity of clinical presentations, treatment responses, and inflammatory processes involved represent an added challenge for health care professionals. Thus, severe asthma management is a complex endeavor, and a thorough and up-to-date understanding of the pathophysiologic characteristics of the patient population promotes effective therapeutic decision-making. This cross-sectional, multicenter study aims to determine the prevalence of oral corticosteroid (OCS) use among severe asthma patients who attend to different sites specialized in the management of severe asthma across Egypt. In addition, the prevalence of eosinophilic phenotype of blood eosinophil count ≥ 150 cells/mm3, prevalence of atopic phenotype, and asthma control will also be studied.

Conditions

Severe Asthma

Outcome Measures

Primary Outcomes (1)

• To describe the prevalence (frequency) of OCS use among severe asthma patients as defined by chronic treatment and/or bursts of OCS use.

  To describe the prevalence (frequency) of OCS use among severe asthma patients as defined by chronic treatment and/or bursts of OCS use.

  12 Months

Secondary Outcomes (9)

• To describe the demographic characteristics of severe eosinophilic asthma patients.

  12 months

• To describe the clinical characteristics of severe eosinophilic asthma patients.

  12 months

• To discover the average OCS dose per year used among severe asthma patients.

  12 months

• To determine the prevalence of the eosinophilic phenotype

  60 months

• To determine the prevalence of the eosinophilic phenotype

  60 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients 18 years and older with severe asthma, per the definition of the GINA 2022 Guidelines \[4\]. Patients will be identified and invited to participate in the study consecutively as they attend their routine clinical visits at the included 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. In addition, patients should provide written, informed consent prior to any study-specific procedures or data collection. 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 18 years or older by the time of study entry
• Patient visiting a participating center for a routine clinical appointment
• The patient is willing and able to provide a blood sample for IgE and eosinophil levels determination as part of their routine clinical visit
• Patients with a 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 (ICF) prior to study entry

You may not qualify if:

• Patients with a diagnosis of chronic obstructive pulmonary disease (COPD) or other chronic respiratory conditions beyond severe asthma
• An acute or chronic condition that, by the investigator's decision, would limit the patient's ability to participate in this study
• Patients who are currently under biologic therapy to treat their severe asthma

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Dakahlia, Dakahlia Governorate, Egypt

Location

Research Site

Sharkia, Sharqia Province, Egypt

Location

Research Site

Alexandria, Egypt

Location

Research Site

Cairo, Egypt

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 28, 2024
• Study Start: March 12, 2024
• Primary Completion: November 28, 2024
• Study Completion: November 28, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

EG (4)