COPDBRIDGE-COPDNCT06646419
Boosting Regional Integration for COP D Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle
An observational study of COPD, run by AstraZeneca at 37 sites in China.
Trial summary
This is a cluster randomized interventional study. Intervention is implemented at a hospital level and will change overall daily practice. 36 county level hospitals are r an domized to the intervention group or control group at the ratio of 2:1 . Total subjects is 1368 and a size of 38 per hospital . Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- How many people
- 1,368 participants
- Where
- 37 sitesChina
- Study dates
- 13 Nov 2024to 21 Sep 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population in this study are in the hospital exacerbation COPD patients with high risk of future exacerbation. Exacerbation COPD is defined as an event characterized by dyspnea and/or cough and sputum that worsen over <14 days. Exacerbation of COPD are often associated with increased local and systemic inflammation caused by airway infection, pollution, or other insults to the lungs.. Screening occurs when AECOPD identified in emergency room, respiratory outpatient clinic or inpatient department. Enrolment occurs when AECOPD treated for several days entering recovery period and transferring to home.
Who may be able to join
- Diagnosed COPD (post- bronchodilator FEV1/FVC < 0.7)
- 40~80 years
- CAT≥10
- At least two moderate or at least one severe exacerbation history in past 1 year
- Able to sign informed consent
Who cannot join
- Continuous triple inhalation therapy for ≥6 months at baseline (include single inhaler and multiple inhalers)
- Stable COPD (symptom such as cough, sputum and shortness of breath are mild or stable, clinical condition has basically returned to pre-exacerbation)
- Comorbidities require/contraindicate long-term use of glucocorticoid treatment: asthma, interstitial lung disease, sarcoidosis, cystic fibrosis, active tuberculosis recurrent aspiration pneumonia ect.
- Serious comorbidities threaten to life expected survival time no more than 1 year: severe heart disease, severe chronic liver, severe kidney disease, cerebrovascular disease with long-term bed rest and malignant tumours ect.
- Not living in the healthcare area
- Patients currently participating in any other interventional studies
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
China37 sites
Research Site
Anyang
Research Site
Baise City
Research Site
Beijing
Research Site
Bijie
Research Site
Changsha
Research Site
Chenzhou
Research Site
Chifeng
Research Site
Chuzhou
Research Site
Deyang
Research Site
Fuyang
Research Site
Hangzhou
Research Site
Hefei
Research Site
Jieyang
Research Site
Jining
Research Site
Jiujiang
Research Site
Kaiyuan
Research Site
Langfang
Research Site
Langzhong
Research Site
Leping
Research Site
Nanchang
Research Site
Nanchong
Research Site
Neijiang
Research Site
Qiannan
Research Site
Qujing
Research Site
Sanmenxia
Research Site
Shaoyang
Research Site
Suzhou
Research Site
Tengzhou
Research Site
Tieling
Research Site
Wenzhou
Research Site
Xiangtan
Research Site
Xiaogan
Research Site
Xinyang
Research Site
Yancheng
Research Site
Yichang
Research Site
Yuling
Research Site
Zaoyang
About this study
Official title: Boosting Regional Integration for COPD Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle: A Multicentre , Prospective, Cluster Randomization, Inteventional Clinical Study
This is a cluster randomized interventional study. Intervention is implemented at a hospital level and will change overall daily practice. 36 county level hospitals are r an domized to the intervention group or control group at the ratio of 2:1 . Total subjects is 1368 and a size of 38 per hospital .
Read the detailed description
The intervention is composed of 3 active components: 1) education on guideline led disease knowledge and transition bundle led management pathway, 2) standardized transition bundle implementation, 3) clinical audit.
Education begins at nearly 4 weeks before first subject in and keep learning every 4 weeks.Standardized transition bundle will be implemented once the first round education is completed. Clinical audit takes up after first subject enrolled and implemented every 12 weeks.The control group will maintain the current usual care practice. Eligible patients will be recruited in both groups and will be followed up every 12 weeks for 48 weeks.
Eligible consented patients will be enrolled consecutively to minimize selection bias. In order to achieve the purpose of continuous enrollment, all patients who visit the outpatient clinic,emergency room, and hospitalized due to exacerbation of COPD will be screened, including newly diagnosed patients or those who have bee n treated.
- Conditions
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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 |
|---|---|---|
| Intervention group | Intervention is implemented at a hospital level and will change overall daily practice. The intervention is composed of 3 active components: 1) education on guideline led disease knowledge and transition bundle led management pathway, 2) standardized transition bundle implementation, 3) clinical audit.Education begins at nearly 4 weeks before first subject in and keep learning every 4 weeks. Standardized transition bundle will be implemented once the first round education is completed. Clinical audit takes up after first subject enrolled and implemented every 12 weeks. | |
| Control group | The control group will maintain the current usual care practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to CID.
To evaluate the the impact of implementation and audit of transition bundle on clinically important deterioration (CID).
Measured: week0-week48
Secondary outcomes (12)
Proportion of patients received long-acting maintenance inhalation with the percentage of days covered (PDC) ≥70%.
To evaluate the the impact of implementation and audit of transition bundle on treatment compliance.
Measured: week 12, 24, 36 and 48
Inhalation therapy consistency rate with guideline.
To evaluate the the impact of implementation and audit of transition bundle on treatment compliance.
Measured: week 12, 24, 36 and 48
Inhaler device compliance,measured by the score of Test of the adherence to inhalers( TAI ) questionnare.
To evaluate the the impact of implementation and audit of transition bundle on treatment compliance.
Measured: week 24 and 48
Correct operation rate of inhalation device.
To evaluate the the impact of implementation and audit of transition bundle on treatment compliance.
Measured: week 24 and 48
Patient satisfaction rate with treatment.
To evaluate the the impact of implementation and audit of transition bundle on treatment satisfaction.
Measured: week 24 and 48
Disease knowledge score of patients.
To evaluate the the impact of implementation and audit of transition bundle on disease knowledge.
Measured: week 24 and 48
Proportion of patients received different categories of long-acting maintenance inhalation.
To evaluate the the impact of implementation and audit of transition bundle on treatment pattern.
Measured: week 12, 24,36 and 48
Rate of moderate or severe exacerbation.
To evaluate the the impact of implementation and audit of transition bundle on exacerbation.
Measured: week 12, 24 and 48
Rate of severe exacerbation.
To evaluate the the impact of implementation and audit of transition bundle on exacerbation.
Measured: week 12, 24 and 48
Rate of cardiovascular events.
To evaluate the the impact of implementation and audit of transition bundle on cardiovascular events.
Measured: week 12, 24 and 48
Change of CAT score.
To evaluate the the impact of implementation and audit of transition bundle on quality of life.
Measured: week 0 to week 48
Percentage change of trough FEV1 and MMEF.
To evaluate the the impact of implementation and audit of transition bundle on PFT.
Measured: week 0 to week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start13 Nov 2024
- Primary completion21 Sep 2026
- Study completion21 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 1,368 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646419
- Sponsor's protocol ID
- D5980L00025
- Acronym
- BRIDGE-COPD
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2024
- Last updated
- 9 Oct 2026
- 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 Vivli.org. All requests 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 approved.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boosting Regional Integration for COPD Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle: A Multicentre , Prospective, Cluster Randomization, Inteventional Clinical Study
- ClinicalTrials.gov ID
- NCT06646419
- Acronym / sponsor ID
- BRIDGE-COPD / D5980L00025
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,368 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 21 Sep 2026 (actual)
- Study completion
- 21 Sep 2026 (actual)
- First posted
- 17 Oct 2024 (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 cluster randomized interventional study. Intervention is implemented at a hospital level and will change overall daily practice. 36 county level hospitals are r an domized to the intervention group or control group at the ratio of 2:1 . Total subjects is 1368 and a size of 38 per hospital .
Detailed description
The intervention is composed of 3 active components: 1) education on guideline led disease knowledge and transition bundle led management pathway, 2) standardized transition bundle implementation, 3) clinical audit.
Education begins at nearly 4 weeks before first subject in and keep learning every 4 weeks.Standardized transition bundle will be implemented once the first round education is completed. Clinical audit takes up after first subject enrolled and implemented every 12 weeks.The control group will maintain the current usual care practice. Eligible patients will be recruited in both groups and will be followed up every 12 weeks for 48 weeks.
Eligible consented patients will be enrolled consecutively to minimize selection bias. In order to achieve the purpose of continuous enrollment, all patients who visit the outpatient clinic,emergency room, and hospitalized due to exacerbation of COPD will be screened, including newly diagnosed patients or those who have bee n treated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | –Intervention is implemented at a hospital level and will change overall daily practice. The intervention is composed of 3 active components: 1) education on guideline led disease knowledge and transition bundle led management pathway, 2) standardized transition bundle implementation, 3) clinical audit.Education begins at nearly 4 weeks before first subject in and keep learning every 4 weeks. Standardized transition bundle will be implemented once the first round education is completed. Clinical audit takes up after first subject enrolled and implemented every 12 weeks. |
| Control group | – | –The control group will maintain the current usual care practice. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population in this study are in the hospital exacerbation COPD patients with high risk of future exacerbation. Exacerbation COPD is defined as an event characterized by dyspnea and/or cough and sputum that worsen over <14 days. Exacerbation of COPD are often associated with increased local and systemic inflammation caused by airway infection, pollution, or other insults to the lungs.. Screening occurs when AECOPD identified in emergency room, respiratory outpatient clinic or inpatient department. Enrolment occurs when AECOPD treated for several days entering recovery period and transferring to home.
Key inclusion criteria (5 listed)
- Diagnosed COPD (post- bronchodilator FEV1/FVC < 0.7)
- 40~80 years
- CAT≥10
- At least two moderate or at least one severe exacerbation history in past 1 year
- Able to sign informed consent
Key exclusion criteria (6 listed)
- Continuous triple inhalation therapy for ≥6 months at baseline (include single inhaler and multiple inhalers)
- Stable COPD (symptom such as cough, sputum and shortness of breath are mild or stable, clinical condition has basically returned to pre-exacerbation)
- Comorbidities require/contraindicate long-term use of glucocorticoid treatment: asthma, interstitial lung disease, sarcoidosis, cystic fibrosis, active tuberculosis recurrent aspiration pneumonia ect.
- Serious comorbidities threaten to life expected survival time no more than 1 year: severe heart disease, severe chronic liver, severe kidney disease, cerebrovascular disease with long-term bed rest and malignant tumours ect.
- Not living in the healthcare area
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
Time to CID.
Time frame: week0-week48
To evaluate the the impact of implementation and audit of transition bundle on clinically important deterioration (CID).
12 secondary outcomes
Proportion of patients received long-acting maintenance inhalation with the percentage of days covered (PDC) ≥70%.
Time frame: week 12, 24, 36 and 48
Inhalation therapy consistency rate with guideline.
Time frame: week 12, 24, 36 and 48
Inhaler device compliance,measured by the score of Test of the adherence to inhalers( TAI ) questionnare.
Time frame: week 24 and 48
Correct operation rate of inhalation device.
Time frame: week 24 and 48
Patient satisfaction rate with treatment.
Time frame: week 24 and 48
Disease knowledge score of patients.
Time frame: week 24 and 48
Proportion of patients received different categories of long-acting maintenance inhalation.
Time frame: week 12, 24,36 and 48
Rate of moderate or severe exacerbation.
Time frame: week 12, 24 and 48
Rate of severe exacerbation.
Time frame: week 12, 24 and 48
Rate of cardiovascular events.
Time frame: week 12, 24 and 48
Change of CAT score.
Time frame: week 0 to week 48
Percentage change of trough FEV1 and MMEF.
Time frame: week 0 to week 48
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 9 Oct 2026.
- 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 Vivli.org. All requests 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 approved.
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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.
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by AstraZeneca at 37 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 5 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 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?
Time to CID. (time frame: week0-week48). 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 9 Oct 2026.