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Improving COPD care through a new management approach

Boosting Regional Integration for COPD Care Through Guided Implementation and Audit of Post Exacerbation Transition Bundle: A Multicentre , Prospective, Cluster Randomization, Inteventional Clinical Study

AstraZeneca · NCT06646419

This study is testing a new way to improve care for people with COPD by providing better education and support in hospitals to see if it helps them feel better over 48 weeks.

Quick facts

Study typeObservational
Enrollment1368 (estimated)
Ages40 Years to 80 Years
SexAll
SponsorAstraZeneca (industry)
Locations37 sites (Anyang and 36 other locations)
Trial IDNCT06646419 on ClinicalTrials.gov

What this trial studies

This observational study aims to enhance the care of patients with Chronic Obstructive Pulmonary Disease (COPD) by implementing a structured transition bundle at the hospital level. A total of 36 county-level hospitals will be randomized into intervention and control groups, with 1368 patients enrolled. The intervention includes education on disease management, standardized implementation of care pathways, and regular clinical audits to assess adherence and outcomes. Patients will be followed for 48 weeks to evaluate the effectiveness of the new approach compared to usual care.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-80 with a diagnosis of COPD who have experienced recent exacerbations.

Not a fit: Patients with stable COPD or serious comorbidities that limit their life expectancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management and outcomes for patients with COPD, particularly after exacerbations.

How similar studies have performed: Previous studies have shown that structured management approaches can improve outcomes in COPD, suggesting potential success for this intervention.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where this trial is running

Anyang and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: COPD

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.