Treatment Efficacy of Systemic Corticosteroids in AECOPD Patients With Higher Blood Eosinophil Levels
Status:
Not yet recruiting
Trial end date:
2024-03-31
Target enrollment:
Participant gender:
Summary
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 > 150ul
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 absolute peripheral blood
eosinophil blood count to guide corticosteroid therapy in AECOPD patients and help the
clinician make an individual decision for each patient.
Phase:
Phase 4
Details
Lead Sponsor:
Capital Medical University
Collaborators:
Beijing Anzhen Hospital Beijing Jingmei Group Hospital Beijing Jishuitan Hospital Beijing Luhe Hospital Beijing Shijingshan Hospital Beijing Tongren Hospital Bejing INFI-SAGACITY TECHNOLOGY CO., LTD Emergency General Hospital Guang'anmen Hospital of China Academy of Chinese Medical Sciences Peking University Xuanwu Hospital, Beijing