Respiratory (Chronic Obstructive Pulmonary Disease)ALSACNCT07315958
Study for Assessing the Prevalence of Airflow Limitation in Outpatients With History of Smoking Attending Cardiology Clinics
An observational study of Respiratory (Chronic Obstructive Pulmonary Disease), run by AstraZeneca at 2 sites in Turkey (Türkiye).
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is a global health concern, associated with structural lung abnormalities causing persistent airflow limitation (AL) and often result from cigarette smoking. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory (Chronic Obstructive Pulmonary Disease)
- How many people
- 1,000 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 8 Oct 2025to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 attending cardiology clinics for any reason: 1. Patients aged 40 years or older. 2. Patients with a smoking history of 10 pack-years or more.
Who may be able to join
- Patients aged 40 years or older.
- Patients with a smoking history of 10 pack-years or more.
- Patients willing and able to complete pulmonary function test, using a spirometer.
- Patients who have provided written consent to participate in the study.
- Patients attending cardiology clinics at the participating centers.
- Patients willing and able to complete the CAAT questionnaire.
Who cannot join
- Patients diagnosed with bronchial asthma. B. Patients who used a bronchodilator for an acute respiratory infection before performing spirometry.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Research Site
Ankara
- Recruiting
Research Site
Istanbul
About this study
Official title: A Multinational, Multicenter, Observational, Prospective Cohort Study for Assessing the Prevalence of Airflow Limitation in Outpatients With History of Smoking Attending Cardiology Clinics
Chronic Obstructive Pulmonary Disease (COPD) is a global health concern, associated with structural lung abnormalities causing persistent airflow limitation (AL) and often result from cigarette smoking. In Turkey, COPD was ranked the third among the mortality causes and the eighth among disability causes, with 9.1% to 19.1% prevalence rate. In the Middle East and North Africa (MENA) region, an increase of 30.6% in age-standardized point prevalence occurred between 1990 and 2019, with an estimated 10.7 million COPD cases. Similarly, in the sub-Saharan Africa region, the highest COPD prevalence rate of 24.8% was observed in South Africa. And in Kenya, East Africa, the pooled point estimate prevalence of COPD was 11.3%. The prevalence of COPD varies substantially between countries, but comparing numbers is challenging because they are recorded in different units and during different periods.
Patients with COPD are more likely to develop cardiovascular disease (CVD). For instance, COPD has been shown to increase the risk of acute myocardial infarction by 40% and stroke by 50%. Likewise, COPD patients with CVD have a considerably higher risk of COPD exacerbations than those without CVD. COPD and CVD have been linked to a worse prognosis primarily related to increased systemic inflammation; the presence of a concomitant disease with COPD leads to reduced quality of life, increased hospitalizations, and worse survival. For instance, every increase of 70 cL/s in forced expiratory volume in 1 second (FEV1) reduces mortality risk by 28%-35% from cardiovascular disease and 68%-72% from respiratory disease. Besides that, smoking has been shown to increase the risk of myocardial infarction (MI) and heart failure (HF) twofold, cigarette smoking toxins promote inflammation systemically, which may result in emphysema and atherosclerosis. Nevertheless, chronic inhalation of irritants, including biomass fuel smoke and air pollutants, produces an innate immune response and a later activation of adaptive immunity that might further amplify inflammation. Similarly, age-related elastin degradation may increase the risk of emphysema and arterial hypertension. On the contrary, physical activity is associated with improved lung function and a lower resting heart rate (RHR); consequently, COPD and CVD are more prevalent in sedentary populations. Observational studies suggest that decreasing the progression of COPD may assist in preventing cardiovascular morbidity and mortality, which is related to more severe respiratory symptoms.
- Keywords
- 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.
Prevalence (number and percentage) of outpatients attending cardiology clinics, with a history of smoking who exhibit concurrent AL consistent with COPD.
Prevalence (number and percentage) of outpatients attending cardiology clinics, with a history of smoking who exhibit concurrent AL consistent with COPD.
Measured: 1 Year
Secondary outcomes (4)
The proportion of patients with CVD who were previously diagnosed with COPD.
The proportion of patients with CVD who were previously diagnosed with COPD.
Measured: 1 Year
The distribution of patients with AL consistent with COPD among AL severity GOLD grades 1-4.
The distribution of patients with AL consistent with COPD among AL severity GOLD grades 1-4.
GOLD 1 = MILD GOLD 2 = Moderate GOLD 3 = Severe GOLD 4 = Very Severe
Measured: 1 Year
CAAT score of patients with AL consistent with COPD.
CAAT score of patients with AL consistent with COPD. 10-20: Medium impact on daily life. 20-30: High impact. >30: Very high impact.
Measured: 1 Year
The severity of COPD
The severity of COPD using GOLD ABE assessment scheme.
Group A: Low Risk, Low Symptoms Group B: Low Risk, High Symptoms Group E: High Risk
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start8 Oct 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory (Chronic Obstructive Pulmonary Disease)Studies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315958
- Sponsor's protocol ID
- D5980R00124
- Acronym
- ALSAC
- Status last verified
- Sep 2026
- First submitted
- 19 Dec 2025
- Last updated
- 21 Sep 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicenter, Observational, Prospective Cohort Study for Assessing the Prevalence of Airflow Limitation in Outpatients With History of Smoking Attending Cardiology Clinics
- ClinicalTrials.gov ID
- NCT07315958
- Acronym / sponsor ID
- ALSAC / D5980R00124
- Keywords
- chronic obstructive pulmonary disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 5 Jan 2026 (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 global health concern, associated with structural lung abnormalities causing persistent airflow limitation (AL) and often result from cigarette smoking. In Turkey, COPD was ranked the third among the mortality causes and the eighth among disability causes, with 9.1% to 19.1% prevalence rate. In the Middle East and North Africa (MENA) region, an increase of 30.6% in age-standardized point prevalence occurred between 1990 and 2019, with an estimated 10.7 million COPD cases. Similarly, in the sub-Saharan Africa region, the highest COPD prevalence rate of 24.8% was observed in South Africa. And in Kenya, East Africa, the pooled point estimate prevalence of COPD was 11.3%. The prevalence of COPD varies substantially between countries, but comparing numbers is challenging because they are recorded in different units and during different periods.
Patients with COPD are more likely to develop cardiovascular disease (CVD). For instance, COPD has been shown to increase the risk of acute myocardial infarction by 40% and stroke by 50%. Likewise, COPD patients with CVD have a considerably higher risk of COPD exacerbations than those without CVD. COPD and CVD have been linked to a worse prognosis primarily related to increased systemic inflammation; the presence of a concomitant disease with COPD leads to reduced quality of life, increased hospitalizations, and worse survival. For instance, every increase of 70 cL/s in forced expiratory volume in 1 second (FEV1) reduces mortality risk by 28%-35% from cardiovascular disease and 68%-72% from respiratory disease. Besides that, smoking has been shown to increase the risk of myocardial infarction (MI) and heart failure (HF) twofold, cigarette smoking toxins promote inflammation systemically, which may result in emphysema and atherosclerosis. Nevertheless, chronic inhalation of irritants, including biomass fuel smoke and air pollutants, produces an innate immune response and a later activation of adaptive immunity that might further amplify inflammation. Similarly, age-related elastin degradation may increase the risk of emphysema and arterial hypertension. On the contrary, physical activity is associated with improved lung function and a lower resting heart rate (RHR); consequently, COPD and CVD are more prevalent in sedentary populations. Observational studies suggest that decreasing the progression of COPD may assist in preventing cardiovascular morbidity and mortality, which is related to more severe respiratory symptoms.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients attending cardiology clinics for any reason: 1. Patients aged 40 years or older. 2. Patients with a smoking history of 10 pack-years or more.
Key inclusion criteria (6 listed)
- Patients aged 40 years or older.
- Patients with a smoking history of 10 pack-years or more.
- Patients willing and able to complete pulmonary function test, using a spirometer.
- Patients who have provided written consent to participate in the study.
- Patients attending cardiology clinics at the participating centers.
Key exclusion criteria (1 listed)
- Patients diagnosed with bronchial asthma. B. Patients who used a bronchodilator for an acute respiratory infection before performing spirometry.
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
Prevalence (number and percentage) of outpatients attending cardiology clinics, with a history of smoking who exhibit concurrent AL consistent with COPD.
Time frame: 1 Year
Prevalence (number and percentage) of outpatients attending cardiology clinics, with a history of smoking who exhibit concurrent AL consistent with COPD.
4 secondary outcomes
The proportion of patients with CVD who were previously diagnosed with COPD.
Time frame: 1 Year
The distribution of patients with AL consistent with COPD among AL severity GOLD grades 1-4.
Time frame: 1 Year
CAAT score of patients with AL consistent with COPD.
Time frame: 1 Year
The severity of COPD
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 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.
AstraZeneca Clinical Study Information Center contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory (Chronic Obstructive Pulmonary Disease), run by AstraZeneca at 2 sites in Turkey (Türkiye).
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 6 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence (number and percentage) of outpatients attending cardiology clinics, with a history of smoking who exhibit concurrent AL consistent with COPD. (time frame: 1 Year). 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 21 Sep 2026.