Acute Exacerbations of COPDNCT03556475
Development of AECOPD Identification Tool (DETECT Study)
An observational study of Acute Exacerbations of COPD, run by AstraZeneca at 7 sites in China.
Trial summary
This study is an observational, multi-center and cross sectional study,to develop an identification tool on purpose of differentiating COPD exacerbation from patients with respiratory symptoms in community hospitals of China. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Exacerbations of COPD
- How many people
- 300 participants
- Where
- 7 sitesChina
- Study dates
- 28 Apr 2020to 18 Jan 2021
- 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: Disease type 1 : Moderate to severe COPD Patients(n=90); Disease type 2 : Patients with AECOPD a) Mild/moderate: n=60 c) Severe: n=60 Disease type 3 : Non-COPD Patients with high risk factors (n=90)
Who may be able to join
- -≥ 40 years old of age.
- Able to adequately understand written and verbal
- A signed and dated written informed consent must be obtained prior to the visits
- Patients see doctors due to suffering respiratory disease below:
- Disease type 1 - diagnosed moderate and severe stable COPD
- Patients with a diagnosis of COPD and documented record with predicted ratio of FEV1 to forced vital capacity (FVC) < 0.70 before the study visit
Show all 12Show fewer
- COPD with moderate to severe airflow obstruction (FEV1<0.8 predicted)
- Disease type 2 - AECOPD
- Patients with a diagnosis of COPD and documented record with predicted ratio of FEV1 to forced vital capacity (FVC) < 0.70 before the study visit
- Patients consult the clinic or the emergency department because of acute worsening with an AECOPD (diagnosed by more than 2 clinical experts and refer to diagnosis criteria of Appendix 2)
- Disease type 3
- -Non-COPD patients with chronic respiratory symptoms such as cough, sputum and wheeze, dyspnea etc. (≥2 high risk factors )
Who cannot join
- Patients with severe cardiovascular disease, including uncontrolled hypertension with drug treatment, unstable angina, myocardial infarction within the last 6 months, NYHA class II congestive heart failure, severe arrhythmia, pericardial effusion, etc.
- Patients with lung cancer, esophageal cancer or mediastinal tumors;
- Patients who participated in any drug clinical trials within 4 weeks before enrollment;
- Patients with severe infection, indicated for intravenous antibiotics, antifungal or antiviral therapy;
- Patients suffering from mental illness and poor compliance;
- Patients inappropriate for inclusion decided by investigator.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Research Site
Beijing
Research Site
Changsha
Research Site
Guangzhou, 510515
Research Site
Shanghai, 200433
Research Site
Shenyang, 110001
Research Site
Xi'an, 710061
Research Site
Xinxiang
About this study
Official title: A Diagnostic Test to Develop an AECOPD Identification Tool Through Characteristic Variables Extracted From Diagnosed AECOPD Patients
This study is an observational, multi-center and cross sectional study,to develop an identification tool on purpose of differentiating COPD exacerbation from patients with respiratory symptoms in community hospitals of China.
Read the detailed description
This is an observational, multi-center and cross-sectional study to develop an AECOPD identification tool. Estimated totally 7 tertiary hospitals with experts in respiratory area will be involved as the study sites. These study sites will cover the regions of China (Eastern, Southern, Northern, Central, Western and Northeastern region), to be representative for the patient features all over the country. The patients will be enrolled in a "consecutive" way, which is, the investigators will recruit the patients who are eligible and consented to participate in this study without personal tendency.
For the enrolled patients, a face to face visit between investigator and patient will be arranged. The evaluation for the symptoms and signs will be performed and the relevant data will be collected on the visit. In addition, other relevant tests (e.g. oxygen saturation, blood test, CAT, etc) and data (demographic, medical history, etc) will be collected on this visit.
- Conditions
- Acute Exacerbations of COPD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Disease 1 | Moderate to severe COPD Patients(n=90) | |
| Disease type 2-1) | Patients with Mild/moderate AECOPD (n=60) | |
| Disease type 2-2) | Patients with Severe AECOPD( n=60) | |
| Disease type 3 | Non-COPD Patients with high risk factors (n=90) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity(Sen) & Specificity(Spe)
Each candidate factors will be tested and weighed. 6-8 factors are estimated to be identified and modelled to form AECOPD identification scale. The validity and efficacy of AECOPD identification tools will be assessed by internal verification.
Measured: Dec2017--Mar2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start28 Apr 2020
- Primary completion18 Jan 2021
- Study completion18 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbations of COPDStudies 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
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian KANG, PhD, Principal investigator, No 155. Nanjing street, Heping District, Liaoning Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556475
- Sponsor's protocol ID
- D5252R00002
- Status last verified
- Apr 2022
- First submitted
- 10 May 2018
- Last updated
- 22 Apr 2022
- 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 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Diagnostic Test to Develop an AECOPD Identification Tool Through Characteristic Variables Extracted From Diagnosed AECOPD Patients
- ClinicalTrials.gov ID
- NCT03556475
- Acronym / sponsor ID
- D5252R00002
- Conditions
- Acute Exacerbations of COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 14 Jun 2018 (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.
This study is an observational, multi-center and cross sectional study,to develop an identification tool on purpose of differentiating COPD exacerbation from patients with respiratory symptoms in community hospitals of China.
Detailed description
This is an observational, multi-center and cross-sectional study to develop an AECOPD identification tool. Estimated totally 7 tertiary hospitals with experts in respiratory area will be involved as the study sites. These study sites will cover the regions of China (Eastern, Southern, Northern, Central, Western and Northeastern region), to be representative for the patient features all over the country. The patients will be enrolled in a "consecutive" way, which is, the investigators will recruit the patients who are eligible and consented to participate in this study without personal tendency.
For the enrolled patients, a face to face visit between investigator and patient will be arranged. The evaluation for the symptoms and signs will be performed and the relevant data will be collected on the visit. In addition, other relevant tests (e.g. oxygen saturation, blood test, CAT, etc) and data (demographic, medical history, etc) will be collected on this visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Disease 1 | – | –Moderate to severe COPD Patients(n=90) |
| Disease type 2-1) | – | –Patients with Mild/moderate AECOPD (n=60) |
| Disease type 2-2) | – | –Patients with Severe AECOPD( n=60) |
| Disease type 3 | – | –Non-COPD Patients with high risk factors (n=90) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Disease type 1 : Moderate to severe COPD Patients(n=90); Disease type 2 : Patients with AECOPD a) Mild/moderate: n=60 c) Severe: n=60 Disease type 3 : Non-COPD Patients with high risk factors (n=90)
Key inclusion criteria (12 listed)
- -≥ 40 years old of age.
- Able to adequately understand written and verbal
- A signed and dated written informed consent must be obtained prior to the visits
- Patients see doctors due to suffering respiratory disease below:
- Disease type 1 - diagnosed moderate and severe stable COPD
Key exclusion criteria (6 listed)
- Patients with severe cardiovascular disease, including uncontrolled hypertension with drug treatment, unstable angina, myocardial infarction within the last 6 months, NYHA class II congestive heart failure, severe arrhythmia, pericardial effusion, etc.
- Patients with lung cancer, esophageal cancer or mediastinal tumors;
- Patients who participated in any drug clinical trials within 4 weeks before enrollment;
- Patients with severe infection, indicated for intravenous antibiotics, antifungal or antiviral therapy;
- Patients suffering from mental illness and poor compliance;
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
Sensitivity(Sen) & Specificity(Spe)
Time frame: Dec2017--Mar2020
Each candidate factors will be tested and weighed. 6-8 factors are estimated to be identified and modelled to form AECOPD identification scale. The validity and efficacy of AECOPD identification tools will be assessed by internal verification.
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 22 Apr 2022.
- CSR\_Synopsis-DETECT.pdfLink provided by the sponsor.
Related trials for Acute Exacerbations of COPD
Recruiting
A Prospective Study of Cardiovascular Risk of Patients Admitted for Acute Exacerbation of COPD
COPD
Not yet recruitingPhase 4
Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency Department With Acute Exacerbation of COPD (ECOPD)
COPD Exacerbation
Not yet recruiting
Evaluating Customized Antibiotic Duration (CDA) Strategy in Acute Exacerbations of COPD
COPD, Acute Exacerbation of COPD
RecruitingObservational study
Study of Hospitalised Patients With Acute Respiratory Conditions
Acute Respiratory Disease, COPD Exacerbation Acute
Not yet recruitingObservational study
The CANadian EXAcerbation of COPD Trial
COPD, AECOPD
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, PhD principal investigator
No 155. Nanjing street, Heping District, Liaoning Province
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Exacerbations of COPD, run by AstraZeneca at 7 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 12 inclusion and 6 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 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Sensitivity(Sen) & Specificity(Spe) (time frame: Dec2017--Mar2020). 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 22 Apr 2022.