Effects of COPD Standardized Management on COPD Exacerbation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3456 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-04

Study Completion Date

2027-04-01

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.

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Detailed Description

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COPD is the most common chronic respiratory disease in China. An effective and standardized condition management strategy is urgently needed to prevent acute exacerbation, improve the quality of life, and avoid premature death due to COPD. COPD management is mainly performed in community-level health institutions. Implementing COPD standardized management in primary care will help improve the level of COPD prevention and treatment in China.

The investigators will carry out a multicenter, adjudicator-blinded, parallel, cluster randomized clinical trial. An estimated number of 96 secondary hospitals across the country will be involved. Each hospital plans to enroll 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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A parallel, cluster randomized trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Statisticians and outcome assessors will be blinded

Study Groups

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Standardized management

Patients will be managed according to recommendations in GOLD guideline and China's guidelines for COPD care.

Group Type EXPERIMENTAL

Standardized COPD management

Intervention Type BEHAVIORAL

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.

1. 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.
2. Long-term follow-up and routine monitoring of symptoms measured by CAT, mMRC and SGRQ.
3. Regular pulmonary function testing for lung function monitoring
4. Strengthened COPD education
5. Behavioral modification, eg. encouragement of influenza/pneumococcal vaccination, providing smoking cessation counseling and pulmonary rehabilitation.

Usual care

Patients will undergo usual care according to current clinical practice in study sites.

Group Type OTHER

Routine COPD management

Intervention Type OTHER

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.

Interventions

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Standardized COPD management

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.

1. 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.
2. Long-term follow-up and routine monitoring of symptoms measured by CAT, mMRC and SGRQ.
3. Regular pulmonary function testing for lung function monitoring
4. Strengthened COPD education
5. Behavioral modification, eg. encouragement of influenza/pneumococcal vaccination, providing smoking cessation counseling and pulmonary rehabilitation.

Intervention Type BEHAVIORAL

Routine COPD management

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.

Intervention Type OTHER

Other Intervention Names

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COPD management according to GOLD and China's guidelines for COPD care

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No