Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT06983340

EXACOS EG Population

Exacerbations and Their Outcomes in Egyptian Patients (EXACOS EG Population): Understanding the Burden of Severe Exacerbations of COPD and the Association Between Frequency of Severe Exacerbations and Clinical and Health-care Utilization Outcomes in Less Well-resourced Countries: Sample of Egyptian Patients.

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
AstraZeneca · Industry
Sex
All
Age
Healthy volunteers
Not accepted

Summary

Chronic obstructive pulmonary disease (COPD) is a common, progressive disease characterized by airflow obstruction which is not fully reversible. Acute exacerbations of COPD (AECOPD) are described as worsening of COPD symptoms (breathlessness, cough, and sputum volume and purulence) beyond normal day to day variation. Between 30-50% of patients with COPD experience at least one AECOPD per year (1). Even a single moderate AECOPD increases risk of future multiple AECOPD events, starting a spiral of excessive disease progression and leading to an increased risk of death (2). AECOPDs have also been associated with other clinical outcomes such as accelerated lung function decline. Studies have shown that AECOPDs are related to future AECOPDs, however, little is known about clinical burden and health care utilization in the COPD population. To date, most of published literature reports a combined category of moderate-severe exacerbations, typically stratifying patients as experiencing frequent (i.e., two or more events per patient-year) vs. infrequent (none or one) exacerbations. In Egypt, COPD is considered one of the most burdensome chronic diseases, with acute exacerbations being directly associated with its burden on patients 'lives. Although no official epidemiological data is available for COPD, its prevalence in Egypt was estimated to be 3.5% in the international epidemiological survey study BREATHE in 2012, while its prevalence in high-risk Egyptian population -defined as population engaged in construction, exposed to biomass fuel, or with smoking history - is estimated to be 9.6%. Moreover, a study reporting on the burden of COPD indicated that the age standardized prevalence of COPD increased by 62% over 3 decades. Regarding AECOPD, studies have explored its reported etiologies and clinical outcomes in Egypt; however, data specifying its incidence and frequency in Egypt is still limited.

Conditions

Timeline

Start date
2025-08-30
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2025-05-21
Last updated
2026-03-18

Source: ClinicalTrials.gov record NCT06983340. Inclusion in this directory is not an endorsement.