Chronic Obstructive Pulmonary Disease COPDREALNCT03131362
Realize the Current Situation of COPD Patients in China
An observational study of Chronic Obstructive Pulmonary Disease COPD, run by AstraZeneca at 1 site in China.
Trial summary
This is a multi-centre, prospective, observational study to realize the current situation of COPD patients in China. About 5000 COPD patients will be enrolled from 50 participating sites around China and followed up for one year. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease COPD
- How many people
- 5,020 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2017to 6 Aug 2020
- 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: Approximately 5000 patients with COPD will be enrolled from 50 tertiary and secondary hospitals in six geographic regions around China in order to recruit a nationally representative study population from 2017 Q2 to 2018 Q2.
Who may be able to join
- Outpatients, more than 40 years old
- Clinically diagnosed as COPD (the patients are clinically diagnosed as COPD based on chronic cough, sputum, wheeze and a history of exposure to harmful factors, and confirmed by spirometry(FEV1/FVC<0.7, post-bronchodilator according to GOLD 2016)
- Sign (or their legally-acceptable representatives must sign) and date the informed consent form indicating that they understand the purpose of and procedure required for the study and are willing to participate in the study.
Who cannot join
- Participated in any interventional clinical trial during the last 30 days
- With acute exacerbation within 4 weeks before enrolment
- Not suitable for study observation judged by investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REALizing and Improving Management of Stable COPD in China--A Multi-centre, Prospective, Observational Study to Realize the Current Situation of COPD Patients in China.
This is a multi-centre, prospective, observational study to realize the current situation of COPD patients in China. About 5000 COPD patients will be enrolled from 50 participating sites around China and followed up for one year. During this study, patients will undergo clinical assessments and receive medical care as determined by their treating physician.
Read the detailed description
This is a multi-centre, prospective, observational study. This study aims to observe the general situation in clinical practice, and the evolution and outcome of current usual care of COPD in China.This is an observational study. It will be carried out under routine clinical practice and the treatment will be determined by patients' treating physicians. Information about exposure to treatments as part of routine care will be collected (dose, frequency and duration).
A multi-stage, stratified and cluster sampling method will be used to select a nationally representative sample from the tertiary and secondary hospitals with respiratory department in six geographic regions around China as the study sites. Approximately 5000 patients with COPD will be enrolled from 50 selected study sites in order to recruit a nationally representative study population and followed up for one year.
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean rate of COPD exacerbations
The mean rate of COPD exacerbations (acute exacerbation number per patient per year).
Measured: within one year
The proportion of hospitalized patients
The proportion of hospitalized patients due to the COPD exacerbations within one year；
Measured: within one year
The distribution of different severity of COPD exacerbations
The distribution will be measured by percentage of patient on each level of severity of COPD exacerbations (mild: requiring an increase in rescue medication≥ 3 puffs / day for at least 2 consecutive days; moderate: requiring systemic glucocorticosteroids and/or antibiotics; severe: hospitalization, emergency room visit or leading to death), the calculation will be based on non-missing data.
Measured: within one year
The mean reduction value of available FEV1
The mean reduction value of available FEV1 after one year from baseline
Measured: within one year
The mean change in CAT
The mean change in CAT total scores after one year from baseline; COPD assessment test (CAT) total score will be derived by summing up the score of all items. Total Scores range 0-40.The COPD influence on patients: 1 stage (mild): 0-10 points; 2 stage (moderate): 11-20 points; 3 stage (severe):21-30 points; 4 stage (very severe):31-40 points.
Measured: within one year
The mean change in mMRC
The mean change in mMRC results after one year from baseline. Modified Medical Research Council Questionnaire (mMRC) will be assessed according to the severity of breathlessness as below:
Grade 0 I only get breathless with strenuous exercise
Grade 1 I get short of breath when hurrying on the level or walking up a slight hill
Grade 2 I walk slower than people of the same age on the level because of breathlessness, or I have to stop for breath when walking on my own pace on the level
Grade 3 I stop for breath after walking about 100 meters or after a few minutes on the level
Grade 4 I am too breathless to leave the house or I am breathless when dressing or undressing
Measured: within one year
The mean change in COPD-Q
The mean change in COPD patients' cognition questionnaire (COPD-Q) total scores after one year from baseline. COPD knowledge Questionnaire (COPD-Q) total score will be derived by summing up the scores from 13 items evaluating patients knowledge and understanding to COPD including 8 forward items: 1point (true), 0 point (false or not sure); 5 reverse items: 1 point (false), 0 point (true or not sure). Then get the total scores.
Measured: within one year
The mean rate of COPD exacerbations by different severity of COPD patients by airway limitation / by A/B/C/D at baseline.
The mean rate of COPD exacerbations (acute exacerbation number per patient per year) by different severity of COPD patients by airway limitation / by A/B/C/D at baseline according to GOLD 2016.
Measured: within one year
The proportion of hospitalized patients by different severity of COPD patients by airway limitation / by A/B/C/D at baseline
The proportion of hospitalized patients due to the COPD exacerbations by different severity of COPD patients by airway limitation / by A/B/C/D at baseline within one year according to GOLD 2016.
Measured: within one year
The mean reduction value of available FEV1 by different severity of COPD by airway limitation / by A/B/C/D patients after one year from baseline
The mean reduction value of available FEV1 by different severity of COPD by airway limitation / by A/B/C/D patients according to GOLD 2016 after one year from baseline
Measured: within one year
Secondary outcomes (12)
The distribution of different severity of COPD patients
The distribution will be measured by the percentage of patient on each level of severity of COPD patients by airway limitation / by A/B/C/D patients at baseline and after one year. The calculation will be based on non-missing data.
Measured: within one year
Distribution of stable COPD medications in mono in total population by drug class
The distribution will be measured by the percentage of patient on each kind of stable COPD medications in mono in total population by drug class (ICS[inhaled corticosteroid], LABA[long-acting beta2-agonist], ICS/LABA[combination long-acting beta2-agonists plus corticosteroids in one inhaler], SABA[short-acting beta2-agonist], SAMA[short-acting muscarinic antagonist], SABA/SAMA [combination short-acting beta2-agonist plus anticholinergic], LAMA[long-acting muscarinic antagonist], methylxanthines, mucolytic, traditional Chinese medicine and others [antibiotics, systemic corticosteroids, vaccines, antioxidant agents, etc]) at baseline and after one year. The calculation will be based on non-missing data.
Measured: within one year
Distribution of stable COPD medications by drug class according to the severity by airway limitation / by A/B/C/D patients
The distribution will be measured by the percentage of stable COPD medications by drug class (ICS[inhaled corticosteroid], LABA[long-acting beta2-agonist], ICS/LABA[combination long-acting beta2-agonists plus corticosteroids in one inhaler], SABA[short-acting beta2-agonist], SAMA[short-acting muscarinic antagonist], SABA/SAMA [combination short-acting beta2-agonist plus anticholinergic], LAMA[long-acting muscarinic antagonist], methylxanthines, mucolytic, traditional Chinese medicine and others [antibiotics, systemic corticosteroids, vaccines, antioxidant agents, etc]) according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year. The calculation will be based on non-missing data.
Measured: within one year
Distribution of medications for COPD exacerbations by drug class including hospital prescribed and pharmacy bought
The distribution will be measured by the percentage of patient on each kind of medications for COPD exacerbations by drug (short-acting bronchodilators, corticosteroids, antibiotics and others) including hospital prescribed and pharmacy bought. The calculation will be based on non-missing data.
Measured: within one year
Distribution of non-drug treatments
The distribution will be measured by the percentage of patient on each kind of non-drug treatments (health education, smoking cessation, exercise of respiratory function and vaccine injection) during the study. The calculation will be based on non-missing data.
Measured: within one year
Patients drug compliance
Patients drug compliance (actual drug taken days/actually prescribed days, and actual drug taken dosage/actually prescribed dosage)
Measured: within one year
Mean total direct COPD cost
Mean total direct COPD cost of the whole year per patient including the stable COPD management cost (medications and non-drug treatments) and the COPD exacerbations cost.
Measured: within one year
Distribution of prescribed stable COPD medications by drug class at each usual visit.
The distribution will be measured by the percentage of patient on each kind of prescribed stable COPD medications by drug class (ICS[inhaled corticosteroid], LABA[long-acting beta2-agonist], ICS/LABA[combination long-acting beta2-agonists plus corticosteroids in one inhaler], SABA[short-acting beta2-agonist], SAMA[short-acting muscarinic antagonist], SABA/SAMA [combination short-acting beta2-agonist plus anticholinergic], LAMA[long-acting muscarinic antagonist], methylxanthines, mucolytic, traditional Chinese medicine and others [antibiotics, systemic corticosteroids, vaccines, antioxidant agents, etc]) on each usual care visit. The calculation will be based on non-missing data.
Measured: within one year
Distribution of stable COPD dosage by drug class according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year.
The distribution will be measured by the percentage of patient on each kind of stable COPD dosage by drug class according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year. The calculation will be based on non-missing data.
Measured: Within one year
Distribution of stable COPD frequency by drug class according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year.
The distribution will be measured by the percentage of patient on each level of stable COPD frequency by drug class ( same as above) according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year.
The calculation will be based on non-missing data.
Measured: Within one year
Patients visit compliance
Patients visit compliance (the mean usual care visit times per patient per year, and the dropout rate at each visit including V0, V1 and TC visits)
Measured: Within one year
Distribution of stable COPD medications in combination in total population by drug class
The distribution will be measured by the percentage of patient on each kind of stable COPD medications in combination in total population by drug class (ICS[inhaled corticosteroid], LABA[long-acting beta2-agonist], ICS/LABA[combination long-acting beta2-agonists plus corticosteroids in one inhaler], SABA[short-acting beta2-agonist], SAMA[short-acting muscarinic antagonist], SABA/SAMA [combination short-acting beta2-agonist plus anticholinergic], LAMA[long-acting muscarinic antagonist], methylxanthines, mucolytic, traditional Chinese medicine and others [antibiotics, systemic corticosteroids, vaccines, antioxidant agents, etc]) at baseline and after one year. The calculation will be based on non-missing data.
Measured: Within one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start30 Jun 2017
- Primary completion6 Aug 2020
- Study completion6 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease 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
- 5,020 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03131362
- Sponsor's protocol ID
- D2287R00114
- Acronym
- REAL
- Status last verified
- Jan 2022
- First submitted
- 20 Mar 2017
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Yang T, Cai B, Cao B, Kang J, Wen F, Chen Y, Jian W, Wang C. REALizing and improving management of stable COPD in China: results of a multicentre, prospective, observational study (REAL). Ther Adv Respir Dis. 2023 Jan-Dec;17:17534666231178692. doi: 10.1177/17534666231178692.
PubMed 37318116Yang T, Cai B, Cao B, Kang J, Wen F, Chen Y, Jian W, Wang C. Exacerbation in patients with stable COPD in China: analysis of a prospective, 52-week, nationwide, observational cohort study (REAL). Ther Adv Respir Dis. 2023 Jan-Dec;17:17534666231167353. doi: 10.1177/17534666231167353.
PubMed 37073797Yang T, Cai B, Cao B, Kang J, Wen F, Chen Y, Jian W, Wang C. Treatment patterns in patients with stable COPD in China: analysis of a prospective, 52-week, nationwide, observational cohort study (REAL). Ther Adv Respir Dis. 2023 Jan-Dec;17:17534666231158283. doi: 10.1177/17534666231158283.
PubMed 37013442Yang T, Cai B, Cao B, Kang J, Wen F, Chen Y, Jian W, Shang H, Wang C. Severity distribution and treatment of chronic obstructive pulmonary disease in China: baseline results of an observational study. Respir Res. 2022 Apr 29;23(1):106. doi: 10.1186/s12931-022-02021-w.
PubMed 35488337Yang T, Cai B, Cao B, Kang J, Wen F, Yao W, Zheng J, Ling X, Shang H, Wang C. REALizing and improving management of stable COPD in China: a multi-center, prospective, observational study to realize the current situation of COPD patients in China (REAL) - rationale, study design, and protocol. BMC Pulm Med. 2020 Jan 13;20(1):11. doi: 10.1186/s12890-019-1000-x.
PubMed 31931767
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REALizing and Improving Management of Stable COPD in China--A Multi-centre, Prospective, Observational Study to Realize the Current Situation of COPD Patients in China.
- ClinicalTrials.gov ID
- NCT03131362
- Acronym / sponsor ID
- REAL / D2287R00114
- Keywords
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,020 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 6 Aug 2020 (actual)
- Study completion
- 6 Aug 2020 (actual)
- First posted
- 27 Apr 2017 (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 is a multi-centre, prospective, observational study to realize the current situation of COPD patients in China. About 5000 COPD patients will be enrolled from 50 participating sites around China and followed up for one year. During this study, patients will undergo clinical assessments and receive medical care as determined by their treating physician.
Detailed description
This is a multi-centre, prospective, observational study. This study aims to observe the general situation in clinical practice, and the evolution and outcome of current usual care of COPD in China.This is an observational study. It will be carried out under routine clinical practice and the treatment will be determined by patients' treating physicians. Information about exposure to treatments as part of routine care will be collected (dose, frequency and duration).
A multi-stage, stratified and cluster sampling method will be used to select a nationally representative sample from the tertiary and secondary hospitals with respiratory department in six geographic regions around China as the study sites. Approximately 5000 patients with COPD will be enrolled from 50 selected study sites in order to recruit a nationally representative study population and followed up for one year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Approximately 5000 patients with COPD will be enrolled from 50 tertiary and secondary hospitals in six geographic regions around China in order to recruit a nationally representative study population from 2017 Q2 to 2018 Q2.
Key inclusion criteria (3 listed)
- Outpatients, more than 40 years old
- Clinically diagnosed as COPD (the patients are clinically diagnosed as COPD based on chronic cough, sputum, wheeze and a history of exposure to harmful factors, and confirmed by spirometry(FEV1/FVC<0.7, post-bronchodilator according to GOLD 2016)
- Sign (or their legally-acceptable representatives must sign) and date the informed consent form indicating that they understand the purpose of and procedure required for the study and are willing to participate in the study.
Key exclusion criteria (3 listed)
- Participated in any interventional clinical trial during the last 30 days
- With acute exacerbation within 4 weeks before enrolment
- Not suitable for study observation judged by investigators.
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 mean rate of COPD exacerbations
Time frame: within one year
The mean rate of COPD exacerbations (acute exacerbation number per patient per year).
The proportion of hospitalized patients
Time frame: within one year
The proportion of hospitalized patients due to the COPD exacerbations within one year；
The distribution of different severity of COPD exacerbations
Time frame: within one year
The distribution will be measured by percentage of patient on each level of severity of COPD exacerbations (mild: requiring an increase in rescue medication≥ 3 puffs / day for at least 2 consecutive days; moderate: requiring systemic glucocorticosteroids and/or antibiotics; severe: hospitalization, emergency room visit or leading to death), the calculation will be based on non-missing data.
The mean reduction value of available FEV1
Time frame: within one year
The mean reduction value of available FEV1 after one year from baseline
The mean change in CAT
Time frame: within one year
The mean change in CAT total scores after one year from baseline; COPD assessment test (CAT) total score will be derived by summing up the score of all items. Total Scores range 0-40.The COPD influence on patients: 1 stage (mild): 0-10 points; 2 stage (moderate): 11-20 points; 3 stage (severe):21-30 points; 4 stage (very severe):31-40 points.
The mean change in mMRC
Time frame: within one year
The mean change in mMRC results after one year from baseline. Modified Medical Research Council Questionnaire (mMRC) will be assessed according to the severity of breathlessness as below: Grade 0 I only get breathless with strenuous exercise Grade 1 I get short of breath when hurrying on the level or walking up a slight hill Grade 2 I walk slower than people of the same age on the level because of breathlessness, or I have to stop for breath when walking on my own pace on the level Grade 3 I stop for breath after walking about 100 meters or after a few minutes on the level Grade 4 I am too breathless to leave the house or I am breathless when dressing or undressing
The mean change in COPD-Q
Time frame: within one year
The mean change in COPD patients' cognition questionnaire (COPD-Q) total scores after one year from baseline. COPD knowledge Questionnaire (COPD-Q) total score will be derived by summing up the scores from 13 items evaluating patients knowledge and understanding to COPD including 8 forward items: 1point (true), 0 point (false or not sure); 5 reverse items: 1 point (false), 0 point (true or not sure). Then get the total scores.
The mean rate of COPD exacerbations by different severity of COPD patients by airway limitation / by A/B/C/D at baseline.
Time frame: within one year
The mean rate of COPD exacerbations (acute exacerbation number per patient per year) by different severity of COPD patients by airway limitation / by A/B/C/D at baseline according to GOLD 2016.
The proportion of hospitalized patients by different severity of COPD patients by airway limitation / by A/B/C/D at baseline
Time frame: within one year
The proportion of hospitalized patients due to the COPD exacerbations by different severity of COPD patients by airway limitation / by A/B/C/D at baseline within one year according to GOLD 2016.
The mean reduction value of available FEV1 by different severity of COPD by airway limitation / by A/B/C/D patients after one year from baseline
Time frame: within one year
The mean reduction value of available FEV1 by different severity of COPD by airway limitation / by A/B/C/D patients according to GOLD 2016 after one year from baseline
12 secondary outcomes
The distribution of different severity of COPD patients
Time frame: within one year
Distribution of stable COPD medications in mono in total population by drug class
Time frame: within one year
Distribution of stable COPD medications by drug class according to the severity by airway limitation / by A/B/C/D patients
Time frame: within one year
Distribution of medications for COPD exacerbations by drug class including hospital prescribed and pharmacy bought
Time frame: within one year
Distribution of non-drug treatments
Time frame: within one year
Patients drug compliance
Time frame: within one year
Mean total direct COPD cost
Time frame: within one year
Distribution of prescribed stable COPD medications by drug class at each usual visit.
Time frame: within one year
Distribution of stable COPD dosage by drug class according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year.
Time frame: Within one year
Distribution of stable COPD frequency by drug class according to the severity by airway limitation / by A/B/C/D patients at baseline and after one year.
Time frame: Within one year
Patients visit compliance
Time frame: Within one year
Distribution of stable COPD medications in combination in total population by drug class
Time frame: Within one year
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 26 Jan 2022.
- Derived from this study: PubMed 37318116Yang T, Cai B, Cao B, Kang J, Wen F, Chen Y, Jian W, Wang C. REALizing and improving management of stable COPD in China: results of a multicentre, prospective, observational study (REAL). Ther Adv Respir Dis. 2023 Jan-Dec;17:17534666231178692. doi: 10.1177/17534666231178692.
- Derived from this study: PubMed 37073797Yang T, Cai B, Cao B, Kang J, Wen F, Chen Y, Jian W, Wang C. Exacerbation in patients with stable COPD in China: analysis of a prospective, 52-week, nationwide, observational cohort study (REAL). Ther Adv Respir Dis. 2023 Jan-Dec;17:17534666231167353. doi: 10.1177/17534666231167353.
- Derived from this study: PubMed 37013442Yang T, Cai B, Cao B, Kang J, Wen F, Chen Y, Jian W, Wang C. Treatment patterns in patients with stable COPD in China: analysis of a prospective, 52-week, nationwide, observational cohort study (REAL). Ther Adv Respir Dis. 2023 Jan-Dec;17:17534666231158283. doi: 10.1177/17534666231158283.
- Derived from this study: PubMed 35488337Yang T, Cai B, Cao B, Kang J, Wen F, Chen Y, Jian W, Shang H, Wang C. Severity distribution and treatment of chronic obstructive pulmonary disease in China: baseline results of an observational study. Respir Res. 2022 Apr 29;23(1):106. doi: 10.1186/s12931-022-02021-w.
- Derived from this study: PubMed 31931767Yang T, Cai B, Cao B, Kang J, Wen F, Yao W, Zheng J, Ling X, Shang H, Wang C. REALizing and improving management of stable COPD in China: a multi-center, prospective, observational study to realize the current situation of COPD patients in China (REAL) - rationale, study design, and protocol. BMC Pulm Med. 2020 Jan 13;20(1):11. doi: 10.1186/s12890-019-1000-x.
- This is a CSR Synopsis.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease COPD, run by AstraZeneca at 1 site 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 3 inclusion and 3 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 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 mean rate of COPD exacerbations (time frame: within one year). The study lists 10 primary outcomes in all. 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 NCT03131362, which also lists 5 linked publications.
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 26 Jan 2022.