Treatment Efficacy of Systemic Corticosteroids in AECOPD Patients With Higher Blood Eosinophil Levels

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 \>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.

Conditions

• Acute Exacerbation of COPD
• Corticosteroid
• Morality
• Lung Diseases, Obstructive
• Blood Eosinophil Count
• COPD
• Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Prednisone

Oral prednisone 40mg/day for five consecutive days

DRUG

Placebo

Oral placebo of 40mg/day for five consecutive days

Sponsors & Collaborators

• Peking University

  collaborator OTHER

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  collaborator OTHER

• Xuanwu Hospital, Beijing

  collaborator OTHER

• Beijing Anzhen Hospital

  collaborator OTHER

• Beijing Tongren Hospital

  collaborator OTHER

• Beijing Luhe Hospital

  collaborator OTHER

• Emergency General Hospital

  collaborator OTHER

• Beijing Jishuitan Hospital

  collaborator OTHER

• Beijing Jingmei Group Hospital

  collaborator UNKNOWN

• Bejing INFI-SAGACITY TECHNOLOGY CO., LTD

  collaborator UNKNOWN

• Chinese People's Liberation Army of China General Hospital

  collaborator UNKNOWN

• Beijing Yanhua Hospital

  collaborator UNKNOWN

• Peking University Shougang Hospital

  collaborator OTHER

• The First Hospital of Fangshan District

  collaborator UNKNOWN

• Liangxiang Hospital

  collaborator UNKNOWN

• Beijing Huairou Hospital

  collaborator OTHER

• Capital Medical University

  lead OTHER

Principal Investigators

• Tong Zhaohui, PhD · Beijing Chao Yang Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-05

Primary Completion

2024-04-30

Completion

2024-05-31

Countries

• China

Study Locations