Chronic Obstructive Pulmonary Disease (COPD) is one of the top three causes of death worldwide now. Acute exacerbations (AEs) of COPD are a risk factor for lung function deterioration, poor quality of life, longer hospitalization, and increased mortality. To date, COPD is associated with a heavy clinical and socioeconomic burden, of which AEs of COPD account for a significant part of the cost of patients with COPD. Although several retrospective cohort studies and post-hoc analyses from randomized controlled trials (RCTs) showed that AECOPD patients with higher blood eosinophils had a shorter length of hospital stay (LOS), lower doses of corticosteroid use, and better response to systematic corticosteroid treatment than those with lower blood eosinophils, the efficacy of systematic corticosteroids in AECOPD patients with higher blood eosinophils has not been confirmed by RCTs. Therefore, this study aims to evaluate if AECOPD patients admitted to hospitals with higher blood eosinophil levels could benefit from systemic corticosteroid therapy. In this study, all eligible AECOPD participants with peripheral blood eosinophil blood count \>2% or \> 300 cells/μL will be randomly assigned (1:1) to either a control group or a systemic corticosteroid group. The control group will receive an oral placebo of 40mg/day for five consecutive days in addition to standard treatment during emergency admission or hospitalization. And systemic corticosteroid group will receive oral prednisone 40mg/day for five consecutive days and standard treatment. This study will provide evidence on using peripheral blood eosinophil blood count to guide corticosteroid therapy in AECOPD patients and help the clinician make an individual decision for each patient.
Data about individual deidentified participants of this trial will be available from the corresponding author Zhaohui Tong (Email: tongzhaohuicy@sina.com) on reasonable request after the main results of the ECHO study have been published.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
11
Oral prednisone 40mg/day for five consecutive days
Oral placebo of 40mg/day for five consecutive days
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China
Treatment failure rates
Collect during index hospitalization and within 30 days after discharge. Treatment failure is defined as either one of events: a) requiring or receiving invasive or non-invasive MV during the index hospitalization; b) requiring or transferring to ICU during the index hospitalization; c) length of index hospitalization longer than 14 days; d) death during the index hospitalization or within 30 days after discharge; e) readmission with acute exacerbations of COPD within 30 days after discharge.
Time frame: 30 days
Requiring or receiving invasive or non-invasive MV during the index hospitalization
Collect during index hospitalization.
Time frame: 14 days
Requiring or transferring to ICU during the index hospitalization
Collect during index hospitalization.
Time frame: 14 days
Length of index hospitalization longer than 14 days
Collect during index hospitalization.
Time frame: 14 days
Death during the index hospitalization or within 30 days after discharge
Collect during index hospitalization and 30-day follow-up.
Time frame: 30 days after discahrge
Readmission with acute exacerbations of COPD within 30 days after discharge
Collect during index hospitalization and 30-day follow-up.
Time frame: 30 days after discahrge
All-cause mortality within 90 days after discharge
Collect during 90-day follow-up.
Time frame: 90 days after discahrge
Readmission rates of AECOPD at 60-day and 90-day follow-ups
Collect during 90-day follow-up.
Time frame: 90 days after discahrge
Time to readmission of AECOPD within 90 days after discharge
Collect during 90-day follow-up.
Time frame: 90 days after discharge
Severer infection or development of pneumonia during hospitalization
Collect during index hospitalization.
Time frame: 14 days
Changes in the scores of Hospital Anxiety and Depression Scale between index hospitalization and 90-day follow-up
Collect during 90-day follow-up. The minimum and maximum values are 14 and 70, respectively. Higher scores mean a worse outcome.
Time frame: 90 days
Changes in the scores of St. George's Respiratory Questionnaire between index hospitalization and 90-day follow-up
Collect during 90-day follow-up. The minimum and maximum values are 1 and 80, respectively. Higher scores mean a worse outcome.
Time frame: 90 days
Changes in the scores of exacerbations of chronic pulmonary disease tool between index hospitalization and 90-day follow-up
Collect during huopitalization and 90-day follow-up. The minimum and maximum values are 14 and 73, respectively. Higher scores mean a worse outcome.
Time frame: 90 days
Changes in the scores of modified Medical Research Council Dyspnoea Scale between index hospitalization and 90-day follow-up
Collect during huopitalization and 90-day follow-up. The minimum and maximum values are 1 and 5, respectively. Higher scores mean a worse outcome.
Time frame: 90 days
Changes in the scores of COPD Assessment Test between index hospitalization and 90-day follow-up
Collect during huopitalization and 90-day follow-up. The minimum and maximum values are 0 and 40, respectively. Higher scores mean a worse outcome.
Time frame: 90 days
Changes in the scores of Transition Dyspnea Index between index hospitalization and 90-day follow-up
Collect during huopitalization and 90-day follow-up.
Time frame: 90 days
Changes in the scores of COPD Exacerbation Recognition Tool during 90-day follow-up
Collect during 90-day follow-up by patients.
Time frame: 90 days after discharge
Length of hospital stay during hospitalization
Collect during huopitalization
Time frame: 14 days
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