An observational study in COPD, sponsored by AstraZeneca. Completed at 37 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by AstraZeneca · Observational
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 .
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 1,368 is above the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
The control group will maintain the current usual care practice.
Time to CID.
To evaluate the the impact of implementation and audit of transition bundle on clinically important deterioration (CID).
Time frame: week0-week48
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 24 and 48
Patient satisfaction rate with treatment.
To evaluate the the impact of implementation and audit of transition bundle on treatment satisfaction.
Time frame: week 24 and 48
Disease knowledge score of patients.
To evaluate the the impact of implementation and audit of transition bundle on disease knowledge.
Time frame: 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.
Time frame: 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.
Time frame: week 12, 24 and 48
Rate of severe exacerbation.
To evaluate the the impact of implementation and audit of transition bundle on exacerbation.
Time frame: week 12, 24 and 48
Rate of cardiovascular events.
To evaluate the the impact of implementation and audit of transition bundle on cardiovascular events.
Time frame: 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.
Time frame: 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.
Time frame: week 0 to week 48
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
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