EXACOS EG Population

NCT06983340 | Withdrawn

• 1 other identifier: D5980R00101
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• To estimate the frequency of severe AECOPD in COPD population in Egypt

  The average annual frequency of severe AECOPD will be estimated in the 3 years prior to index date and divided by 3.

  3 Years

• To describe any time trends in the frequency of severe exacerbations throughout the 3 years prior to index date

  This will guide the categorization of patients into mutually-exclusive groups of severe AECOPD frequency. We expect the following categories which will be refined upon data descriptive analyses: * 0 events * 1 severe event * 2 severe events * 3 severe events * \>3 severe events The distribution of exacerbations across the entire 3-year period will also be described.

  3 Years

Secondary Outcomes (5)

• To measure the Modified Medical Research Council (mMRC) dyspnea scale score at time of the study visit

  12 Months

• To describe the clinical impact of COPD on the patient

  3 Years

• To quantify health care resource utilization by number of severe AECOPD over the 3 years prior to index date.

  3 Years

• To quantify health care resource utilization by number of severe AECOPD over the 3 years prior to index date.

  3 Years

• To quantify health care resource utilization by number of severe AECOPD over the 3 years prior to index date.

  3 years

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

Patients, treated by pulmonologists, with an investigator-confirmed diagnosis of COPD for at least 3 years from the index date (the date that signed Informed Consent was obtained) and who meet all of the inclusion and none of the exclusion criteria detailed below will be included. The intention is to study a broad COPD patient population, so minimal eligibility criteria will be applied.

You may qualify if:

• are over the age of 40 years old;
• have had an investigator-confirmed diagnosis of COPD of at least 3 years prior to the index date;
• have COPD-related data recorded in medical records for at least 3 years prior to the index date, including spirometry (at least one FEV1 measurement) and medication data;
• have signed a written Informed Consent Form

You may not qualify if:

• \. have a diagnosis of bronchiectasis, sarcoidosis, Interstitial Lung Diseases, or Idiopathic pulmonary fibrosis. This is because differentiating deteriorations in symptoms/exacerbations in these individuals at attributing them to COPD is impossible.

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 21, 2025
• Study Start: August 30, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03