Effects of COPD Standardized Management on COPD Exacerbation

This is a multi-center, parallel-group,cluster randomised trial involving secondary hospitals across China. The objective is to evaluate the effect of COPD on reducing moderate-to-severe exacerbations during 12 months follow-up in primary-level medical institutions.

COPD is the most common chronic respiratory disease in China and has caused significant economic and disease burden. An effective and standardized condition management strategy is urgently needed to reduce the incidence of acute exacerbation, improve the quality of patients' life, and avoid premature death caused by COPD. At present, management of COPD is mainly conducted in community-level health institutions. Implementing standardized management of COPD in primary care will help improve the level of COPD prevention and treatment in China.

We will carry out a multicenter, adjudicator-blinded, parallel, cluster randomized clinical trial, involving 96 secondary hospitals across the country. Each hospital enrolls 36 patients with COPD. The hospitals will be randomly allocated into standardized management (SM) group and control group. In SM group, standardized COPD management based-on guidelines will be delivered to patients, including inhaler use for initial and maintenance therapy, regular follow-up, long-term monitoring of lung function and respiratory symptoms, patient education, and favorable lifestyle changes. In control group, patients will receive routine care as usual. In both groups, moderate and severe exacerbations will be collected within 12 months follow-up after randomization. Group difference in annual exacerbation rate will be examined to evaluate the effect of standardized management of COPD on acute exacerbation of COPD in primary care.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥40 years
2. Newly diagnosed COPD patients with post-bronchodilator FEV1/FVC \<70% or previously diagnosed of COPD by physicians and confirmed by PFT.
3. Baseline COPD Assessment Test (CAT) score ≥10
4. Local residents who will be accessible and available for follow-up during trial
5. Written informed consent

Exclusion Criteria:

1. Pregnancy, breastfeeding or potential pregnancy
2. Primary diagnosis of asthma, including Asthma-COPD overlap syndrome.
3. Having severe cognitive dysfunction
4. Severely ill with less than 12-month life expectancy
5. Patients with alcohol abuse history
6. Have participated in similar trials or are undergoing other clinical trials
7. Refuses or unable to give informed consent
8. Planning to move
9. Contraindicated to maintenance medicine
10. Unstable cardiovascular conditions (eg., angina, myocardial infarction, ascending aortic aneurysm) that may predispose patients absolutely contraindicative to PFT during follow-up.
11. Having pneumothorax currently or planning to undergo thoracic/abdominal, ophthalmic, or brain surgery that are relatively contraindicative to PFT within next 6 months.
12. A recent exacerbation with antibiotics and/or oral or intravenous systemic glucocorticoids used within 30 days prior to screening.
13. Having one or more exacerbations requiring hospitalization in the recent 30 days prior to screening.