Asthma-COPD Overlap SyndromeNCT02600221
A Non-interventional Study to Investigate the Current Situation of Asthma-COPD Overlap Syndrome in Patients Over Age 40 With Persistent Airflow Limitation in China
An observational study of Asthma-COPD Overlap Syndrome, run by AstraZeneca at 13 sites in China.
Trial summary
To investigate the distributions of the patients with ACOS, asthma and COPD over age 40 with chronic airflow limitation in China. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Asthma-COPD Overlap Syndrome
- How many people
- 2,016 participants
- Where
- 13 sitesChina
- Study dates
- 22 Oct 2015to 24 Oct 2016
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be about 2000 outpatients, men or women, over age 40, with a clinical diagnosis of asthma, COPD or ACOS with persistent airflow limitation（post-BD FEV1/FVC<0.7）in China from Q4,2015 to Q3,2016.
Who may be able to join
- Outpatients, age ≥ 40 years Clinically diagnosed as asthma, COPD/chronic bronchitis/emphysema or ACOS at least 12 months With persistent airflow limitation (post-BD FEV1/FVC<0.7) Signed informed consent forms
Who cannot join
- Have been involved in other clinical trial within 3 months Having other respiratory diseases which can influence airflow, such as lung cancer, tuberculosis, pneumonia, bronchiectasis, etc With acute exacerbation Inability to understand the study procedures or inability/reluctance to answer questionnaire judged by the investigator
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Research Site
Beijing, Beijing Municipality
Research Site
Changsha, Hunan
Research Site
Chengdou, Sichuan
Research Site
Chongqing, Chongqing Municipality
Research Site
Guangzhou, Guangdong
Research Site
Haikou, Hainan
Research Site
Hangzhou, Zhejiang
Research Site
Hohhot, Inner Mongolia
Research Site
Shanghai, Shanghai Municipality
Research Site
Shenyang, Liaoning
Research Site
Tianjin, Tianjin Municipality
Research Site
Xi’an, Shanxi
Research Site
Zhengzhou, Henan
About this study
To investigate the distributions of the patients with ACOS, asthma and COPD over age 40 with chronic airflow limitation in China.
Read the detailed description
Sites must be tier 3 hospitals in China. Investigators will mainly be determined according to the following criteria:
- Respiratory physicians working in the respiratory department of tier 3 hospitals
- To include the expected number of patients in a maximum of 12 months, physicians should manage a reasonable number of asthma, COPD or ACOS over age 40 with persistent airflow limitation (post-BD FEV1/FVC<0.7).
- Physicians should have patients' spirometric data available in the patient's medical files (post-BD FEV1%pred and post-BD FEV1/FVC).
This NIS will collect the data (e.g. medical record, patient or physician-reported data) from about 2000 consecutive outpatients with persistent airflow limitation(post-BD FEV1/FVC<0.7) in about 20 sites in China for one year. Each site will recruit about 50-150 patients successively.
The data will be collected under routine clinical practice. The treatments or examinations will be determined by their treating physicians. The data are expected to reflect the actual situation about ACOS.
The study population will be about 2000 outpatients, men or women, over age 40, with a clinical diagnosis of asthma, COPD or ACOS with persistent airflow limitation（post-BD FEV1/FVC<0.7）in China from Q4,2015 to Q3,2016.
- Conditions
- Asthma-COPD Overlap Syndrome
- Keywords
- ACOS
- Medical subject headings
- Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of ACOS among the patients over age 40 with persistent airflow limitation (post-BD FEV1/FVC<0.7) based on GINA and GOLD 2015 definition
Measured: one day
Secondary outcomes (11)
- The proportions of COPD and asthma, respectively, among the patients over age 40 with persistent airflow limitation (post-BD FEV1/FVC<0.7) based on GINA and GOLD 2015 definition.
Measured: one day
- The distributions of the severity of airflow limitation according to GOLD lung function grading based on post-BD FEV1 in patients with ACOS, COPD or asthma.
Measured: one day
- The distribution of groups according to GOLD 2015 group definition (A,B,C,D) in patients with ACOS or COPD.
Measured: one day
- The distribution of medication by drug class in patients with ACOS, Asthma and COPD.
Measured: one day
- The proportions of previous diagnosis as asthma/COPD/chronic bronchitis/emphysema in the ACOS patients.
Measured: one day
The number of Acute exacerbations history in 12 months before the visit
Measured: one day
The severity of Acute exacerbations history in 12 months before the visit
Measured: one day
The days of hospitalization or emergency room visit of Acute exacerbations history in 12 months before the visit
Measured: one day
Severity of ACOS patients evaluated using CAT (mild, moderate, severe and very severe) in ACOS patients
Measured: one day
Severity of ACOS patients evaluated using ACQ-5 (complete control, good control and uncontrolled) in ACOS patients
Measured: one day
Severity of ACOS patients evaluated using mMRC (0, 1, 2, 3 and 4) in ACOS patients
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study start22 Oct 2015
- Primary completion24 Oct 2016
- Study completion24 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma-COPD Overlap SyndromeStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,016 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Kang, Doctor of Medicine, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600221
- Sponsor's protocol ID
- D2287R00102
- Status last verified
- Oct 2017
- First submitted
- 29 Oct 2015
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kang J, Zheng J, Cai B, Wen F, Yao W, Zhang X, Chen Y, Wang G, Li W, Cao J. Current situation of asthma-COPD overlap in Chinese patients older than 40 years with airflow limitation: a multicenter, cross-sectional, non-interventional study. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620961699. doi: 10.1177/1753466620961699.
PubMed 33103591
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study to Investigate the Current Situation of Asthma-COPD Overlap Syndrome in Patients Over Age 40 With Persistent Airflow Limitation in China
- ClinicalTrials.gov ID
- NCT02600221
- Acronym / sponsor ID
- D2287R00102
- Conditions
- Asthma-COPD Overlap Syndrome
- Keywords
- ACOS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,016 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2015 (actual)
- Primary completion
- 24 Oct 2016 (actual)
- Study completion
- 24 Oct 2016 (actual)
- First posted
- 9 Nov 2015 (estimated)
- 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.
To investigate the distributions of the patients with ACOS, asthma and COPD over age 40 with chronic airflow limitation in China.
Detailed description
Sites must be tier 3 hospitals in China. Investigators will mainly be determined according to the following criteria:
- Respiratory physicians working in the respiratory department of tier 3 hospitals
- To include the expected number of patients in a maximum of 12 months, physicians should manage a reasonable number of asthma, COPD or ACOS over age 40 with persistent airflow limitation (post-BD FEV1/FVC<0.7).
- Physicians should have patients' spirometric data available in the patient's medical files (post-BD FEV1%pred and post-BD FEV1/FVC).
This NIS will collect the data (e.g. medical record, patient or physician-reported data) from about 2000 consecutive outpatients with persistent airflow limitation(post-BD FEV1/FVC<0.7) in about 20 sites in China for one year. Each site will recruit about 50-150 patients successively.
The data will be collected under routine clinical practice. The treatments or examinations will be determined by their treating physicians. The data are expected to reflect the actual situation about ACOS.
The study population will be about 2000 outpatients, men or women, over age 40, with a clinical diagnosis of asthma, COPD or ACOS with persistent airflow limitation（post-BD FEV1/FVC<0.7）in China from Q4,2015 to Q3,2016.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be about 2000 outpatients, men or women, over age 40, with a clinical diagnosis of asthma, COPD or ACOS with persistent airflow limitation（post-BD FEV1/FVC<0.7）in China from Q4,2015 to Q3,2016.
Key inclusion criteria (1 listed)
- Outpatients, age ≥ 40 years Clinically diagnosed as asthma, COPD/chronic bronchitis/emphysema or ACOS at least 12 months With persistent airflow limitation (post-BD FEV1/FVC<0.7) Signed informed consent forms
Key exclusion criteria (1 listed)
- Have been involved in other clinical trial within 3 months Having other respiratory diseases which can influence airflow, such as lung cancer, tuberculosis, pneumonia, bronchiectasis, etc With acute exacerbation Inability to understand the study procedures or inability/reluctance to answer questionnaire judged by the investigator
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
The proportion of ACOS among the patients over age 40 with persistent airflow limitation (post-BD FEV1/FVC<0.7) based on GINA and GOLD 2015 definition
Time frame: one day
11 secondary outcomes
- The proportions of COPD and asthma, respectively, among the patients over age 40 with persistent airflow limitation (post-BD FEV1/FVC<0.7) based on GINA and GOLD 2015 definition.
Time frame: one day
- The distributions of the severity of airflow limitation according to GOLD lung function grading based on post-BD FEV1 in patients with ACOS, COPD or asthma.
Time frame: one day
- The distribution of groups according to GOLD 2015 group definition (A,B,C,D) in patients with ACOS or COPD.
Time frame: one day
- The distribution of medication by drug class in patients with ACOS, Asthma and COPD.
Time frame: one day
- The proportions of previous diagnosis as asthma/COPD/chronic bronchitis/emphysema in the ACOS patients.
Time frame: one day
The number of Acute exacerbations history in 12 months before the visit
Time frame: one day
The severity of Acute exacerbations history in 12 months before the visit
Time frame: one day
The days of hospitalization or emergency room visit of Acute exacerbations history in 12 months before the visit
Time frame: one day
Severity of ACOS patients evaluated using CAT (mild, moderate, severe and very severe) in ACOS patients
Time frame: one day
Severity of ACOS patients evaluated using ACQ-5 (complete control, good control and uncontrolled) in ACOS patients
Time frame: one day
Severity of ACOS patients evaluated using mMRC (0, 1, 2, 3 and 4) in ACOS patients
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Derived from this study: PubMed 33103591Kang J, Zheng J, Cai B, Wen F, Yao W, Zhang X, Chen Y, Wang G, Li W, Cao J. Current situation of asthma-COPD overlap in Chinese patients older than 40 years with airflow limitation: a multicenter, cross-sectional, non-interventional study. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620961699. doi: 10.1177/1753466620961699.
- CSR SynopsisLink provided by the sponsor.
Related trials for Asthma-COPD Overlap Syndrome
Not yet recruiting
Effect of Video Game-Based Breathing Exercises on Respiratory Dysfunction in ACOS
Asthma-COPD Overlap Syndrome, Pulmonary Rehabilitation
Not yet recruitingObservational study
Blood Exosomal Multi-omics and Lung Radiomics for Predicting Efficacy and Prognosis of Severe Eosinophilic ACOS With Biologics
Severe Eosinophilic ACOS (Asthma-COPD Overlap)
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.
Jian Kang, Doctor of Medicine principal investigator
First Hospital of China Medical University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma-COPD Overlap Syndrome, run by AstraZeneca at 13 sites in China.
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 1 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: finished, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of ACOS among the patients over age 40 with persistent airflow limitation (post-BD FEV1/FVC<0.7) based on GINA and GOLD 2015 definition (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02600221, which also lists 1 linked publication.
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 17 Oct 2017.