Standardized COPD care to reduce exacerbations

Effect of Standardized Disease Management on Exacerbation of COPD in Primary Health Care in China: a Multicenter, Adjudicator-Blinded, Parallel, Cluster Randomized Clinical Trial

This project will test whether delivering guideline-based, standardized COPD care at local hospitals can reduce moderate-to-severe flare-ups over 12 months in people aged 40+ with airflow obstruction and symptoms or recent exacerbations.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 3456 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: China-Japan Friendship Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT04664491 on ClinicalTrials.gov

What this trial studies

This is a multicenter, parallel-group, cluster-randomized trial enrolling about 96 secondary hospitals across China, with each hospital planned to recruit roughly 36 patients. Hospitals are randomized to provide either guideline-based standardized COPD management or routine care, and outcome adjudicators are blinded to group assignment. The standardized program includes initiation and maintenance inhaler therapy, regular follow-up visits, long-term lung function and symptom monitoring, patient education, and support for healthier lifestyle changes. The primary outcome is the difference in annual moderate-to-severe exacerbation rates during 12 months of follow-up.

Who should consider this trial

Good fit: Ideal candidates are people aged 40 or older with post-bronchodilator FEV1/FVC <70% who have a CAT score ≥10 or a history of exacerbation in the prior 12 months and can attend local follow-up visits and provide consent.

Not a fit: Patients unlikely to benefit include those with a primary diagnosis of asthma, severe cognitive dysfunction, very limited life expectancy, pregnancy or breastfeeding, significant alcohol-abuse history, or those already enrolled in similar intensive COPD programs.

Why it matters

Potential benefit: If successful, this approach could lower the number of moderate-to-severe COPD exacerbations, reduce hospitalizations, and improve patients' quality of life.

How similar studies have performed: Previous programs that combined optimized inhaler therapy, regular follow-up, and education have reduced exacerbations and improved outcomes, but large multicenter cluster randomized implementations in primary-care settings are less common.

Eligibility criteria

Inclusion Criteria:

1. Aged ≥40 years
2. Post-bronchodilator FEV1/FVC \<70%
3. Baseline CAT score ≥10 or history of exacerbation in previous 12 months, defined as any use of oral antibiotics and/or oral or nebulized corticosteroids for increased cough, sputum and dyspnea, or exacerbation requiring hospitalization/ emergency admission.
4. Local residents who live nearby and can be followed up throughout study period
5. Written informed consent

Exclusion Criteria:

1. Pregnancy, breastfeeding, or potential pregnancy
2. Primary diagnosis of asthma
3. Having severe cognitive dysfunction
4. Severely ill with less than 12-month life expectancy
5. Patients with alcohol abuse history are excluded as alcoholic individuals may have low adherence to the study. Alcohol abuse is defined as an average alcohol intake \>80 g per day within recent two weeks, or daily intake of ≥40 g alcohol in men, and ≥20 g alcohol in women for more than 5 years.
6. Have participated in similar trials or are undergoing other clinical trials
7. Refuses or unable to give informed consent
8. Plan to move
9. Contraindicated to maintenance medicine.
10. Unstable cardiovascular conditions (e.g., angina, myocardial infarction, ascending aortic aneurysm) that may prevent patients performing spirometry.
11. Relative contraindications to spirometry, including current pneumothorax or planning to undergo thoracic/abdominal, ophthalmic or brain surgeries within next 6 months.
12. Comorbid lung disease including bronchiectasis and tuberculosis, or undergoing anti-tuberculosis treatment
13. Recent exacerbation treated with antibiotics and/or oral or nebulized corticosteroids within 30 days prior to enrolment.
14. Exacerbation requiring emergency admission or hospitalization within 30 days prior to enrolment.

Where this trial is running

Beijing, Beijing Municipality

• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Chen Wang, MD, Ph.D — China-Japan Friendship Hospital
• Study coordinator: Ting Yang, MD, Ph.D

Conditions: Chronic Obstructive Pulmonary Disease, COPD, Standardized Management, Maintenance Therapy, Follow-Up and Monitoring, Lung Function, COPD Symptoms