Chronic Obstructive Pulmonary DiseaseEXACOS EGNCT06983340
EXACOS EG Population
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 1. 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.
About this study
Official title: 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.
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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 Years
Secondary outcomes (5)
To measure the Modified Medical Research Council (mMRC) dyspnea scale score at time of the study visit
Medical Research Council (MRC) dyspnea scale grade, as measured during the index date visit
Measured: 12 Months
To describe the clinical impact of COPD on the patient
CAT score as measured during the index date visit
Measured: 3 Years
To quantify health care resource utilization by number of severe AECOPD over the 3 years prior to index date.
- number of emergency department visits
Measured: 3 Years
To quantify health care resource utilization by number of severe AECOPD over the 3 years prior to index date.
- number and length of hospitalizations
Measured: 3 Years
To quantify health care resource utilization by number of severe AECOPD over the 3 years prior to index date.
- COPD maintenance prescriptions over the 3 years prior to the index date
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start30 Aug 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: Study withdrawn since it was rejected by local regulatory authority.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983340
- Sponsor's protocol ID
- D5980R00101
- Acronym
- EXACOS EG
- Status last verified
- Mar 2026
- First submitted
- 23 Apr 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06983340
- Acronym / sponsor ID
- EXACOS EG / D5980R00101
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study withdrawn since it was rejected by local regulatory authority.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 1. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To estimate the frequency of severe AECOPD in COPD population in Egypt
Time frame: 3 Years
The average annual frequency of severe AECOPD will be estimated in the 3 years prior to index date and divided by 3.
To describe any time trends in the frequency of severe exacerbations throughout the 3 years prior to index date
Time frame: 3 Years
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.
5 secondary outcomes
To measure the Modified Medical Research Council (mMRC) dyspnea scale score at time of the study visit
Time frame: 12 Months
To describe the clinical impact of COPD on the patient
Time frame: 3 Years
To quantify health care resource utilization by number of severe AECOPD over the 3 years prior to index date.
Time frame: 3 Years
To quantify health care resource utilization by number of severe AECOPD over the 3 years prior to index date.
Time frame: 3 Years
To quantify health care resource utilization by number of severe AECOPD over the 3 years prior to index date.
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the frequency of severe AECOPD in COPD population in Egypt (time frame: 3 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.