Effects of COPD Standardized Management on COPD Exacerbation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: Standardized COPD management
* Other: Routine COPD management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥40 years Newly diagnosed COPD patients with post-bronchodilator FEV1/FVC <70% or previously diagnosed of COPD by physicians and confirmed by PFT. Baseline COPD Assessment Test (CAT) score ≥10 Local residents who will be accessible and available for follow-up during trial Written informed consent Exclusion Criteria: Pregnancy, breastfeeding or potential pregnancy Primary diagnosis of asthma, including Asthma-COPD overlap syndrome. Having severe cognitive dysfunction Severely ill with less than 12-month life expectancy Patients with alcohol abuse history Have participated in similar trials or are undergoing other clinical trials Refuses or unable to give informed consent Planning to move Contraindicated to maintenance medicine Unstable cardiovascular conditions (eg., angina, myocardial infarction, ascending aortic aneurysm) that may predispose patients absolutely contraindicative to PFT during follow-up. Having pneumothorax currently or planning to undergo thoracic/abdominal, ophthalmic, or brain surgery that are relatively contraindicative to PFT within next 6 months. A recent exacerbation with antibiotics and/or oral or intravenous systemic glucocorticoids used within 30 days prior to screening. Having one or more exacerbations requiring hospitalization in the recent 30 days prior to screening.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standardized management<br>Patients will be managed according to recommendations in GOLD guideline and China's guidelines for COPD care. | Behavioral: Standardized COPD management<br>* In standardized management group, patients will receive a multifaceted and integrated disease management that follows recommendations in GOLD 2020 and China Guideline on COPD care. It contains the components below. Maintenance therapy after initial treatment. In this study, patients' initial therapy is the prescribed inhalers at baseline. Maintenance therapy is the medications (LABA, LAMA, or ICS) prescribed for regular or long-term use after initial therapy. Long-term follow-up and routine monitoring of symptoms measured by CAT, mMRC and SGRQ. Regular pulmonary function testing for lung function monitoring Strengthened COPD education Behavioral modification, eg. encouragement of influenza/pneumococcal vaccination, providing smoking cessation counseling and pulmonary rehabilitation.<br>* Other names: COPD management according to GOLD and China's guidelines for COPD care;|
| Other: Usual care<br>Patients will undergo usual care according to current clinical practice in study sites. | Other: Routine COPD management<br>* Patients will undergo usual care according to current clinical practice in study sites. Usual care is the routine care provided to patients. Prescription and dispense of medicine for COPD initial and maintenance therapy will be at the discretion of doctors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual rate of moderate and severe COPD exacerbations | Annual rate is an estimated mean number of exacerbations per patient per year | 12 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective assessments for secondary outcomes | Exacerbation numbers and the first exacerbation, hospitalisation, cost-effectiveness, lung function and respiratory symptoms, improvement of self-management. | 12 months from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Standardized Management, Maintenance Therapy, Follow-Up and Monitoring, Lung Function, COPD Symptoms