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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Prednisone

Criteria

Inclusion Criteria:

• 1. Aged between 40 and 80 years old;

• 2. Current or former cigarette smokers (≥10 packs per year);

• 3. Spirometry-verified COPD (defined as postbronchodilator forced expiratory volume in the first second (FEV1)/ forced vital capacity (FVC) ≤ 0.70);

• 4. Within 72 hours of emergency admission or within 24 hours of hospitalization;

• 5. The initial absolute peripheral eosinophil count >150ul/L which was tested within 72 hours of emergency admission or 24 hours within hospitalization;

• 6. Current AECOPD meet the definition of AECOPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline;

• 7. Written informed consent before inclusion.

Exclusion Criteria:

• 1. Admission due to other diseases (pneumonia, pneumothorax, ect);

• 2. Participating in or completed another drug trial within 90 days;

• 3. Pregnancy or lactation;

• 4. Require invasive mechanical ventilation (IMV) or transfer to intensive care unit (ICU) within 24 hours after emergency admission or hospitalization;

• 5. With complications that may cause eosinophilia;

• 6. With pulmonary embolism in the past two years before emergency admission or hospitalization;

• 7. With myocardial infarction in the past four weeks before emergency admission or hospitalization, uncontrollable congestive heart failure or arrhythmia;

• 8. With comorbidity that may influence the immune system;

• 9. With neuromuscular disease affecting the respiratory system;

• 10. Pulmonary interstitial disease or active tuberculosis or bronchiectasis;

• 11. Systemic fungal infection;

• 12. Previous lung surgery, including thoracotomy or bronchoscopic lung volume reduction surgery;

• 13. Received prednisone ≥ 60mg in the past three days before emergency admission or hospitalization (or equivalent doses of other corticosteroid)；

• 14. Allergic or intolerant to corticosteroid;

• 15. Uncontrollable severe psychiatric illnesses even with medication, cognitive impairment, and severe language difficulties;

• 16. Life expectancy less than three months.