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Recruiting NCT04664491

Effects of COPD Standardized Management on COPD Exacerbation

Trial Parameters

Condition Chronic Obstructive Pulmonary Disease
Sponsor China-Japan Friendship Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 3,456
Sex ALL
Min Age 40 Years
Max Age N/A
Start Date 2023-02-04
Completion 2026-06-30
Interventions
Standardized COPD managementRoutine COPD management

Brief Summary

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.

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

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