Treatment Efficacy of Systemic Corticosteroids in AECOPD Patients With Higher Blood Eosinophil Levels
Key facts
- Who runs it
- Capital Medical University
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- Phase
- Phase 4
- People taking part
- 11 people enrolled
- Started
- 5 Mar 2023
- Ended
- 31 May 2024
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Prednisone
- Placebo
- Record updated
- 28 August 2024
- Why it stopped
- Difficulty in recruiting subjects
Who can take part
- Age
- 40 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 28 criteriaShow less
Who can take part
- Within 24 hours of admission
- Aged between of 40 and 80 years old
- Established clinical history of COPD with spirometry-verified COPD (defined as post-bronchodilator forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ≤ 0.70)
- AECOPD diagnosis in accordance with the GOLD guideline (An acute worsening of respiratory symptoms that result in additional therapy)12
- Current or former cigarette smokers (≥10 packs per year)
- Blood eosinophil count > 2% or >300 cells/μL tested within 24 hours of admission
- Signed informed consent
Who cannot take part
- Received prednisone ≥ 60 mg in the past three days (or equivalent doses of other corticosteroid)
- Participating in or completed another drug trial within 90 days
- Thoracotomy or bronchoscopic lung volume reduction surgery history
- Admission due to other diseases (pneumonia, pneumothorax, pulmonary interstitial disease, active tuberculosis or bronchiectasis, ect)
- Allergic or intolerant to corticosteroid
- Myocardial infarction, uncontrollable congestive heart failure or arrhythmia within the past four weeks
- Malignant tumor
- Neuromuscular disease affecting the respiratory system
- Systemic fungal infection
- Adrenocortical insufficiency history
- Diabetes mellitus with poor glycemic control
- Uncontrollable severe psychiatric illnesses even with medication, cognitive impairment, and severe language difficulties
- ALT ≥ 100U/L or AST ≥ 80U/L
- Serum creatinine ≥ 162umol/L
- Regular use of glucocorticoid ≥3 months
- Pregnancy or lactation
- Severe COPD exacerbation requiring invasive mechanical ventilation (IMV) or transfer to ICU within 24 hours after emergency admission or hospitalization
- With complications that may cause eosinophilia
- Pulmonary embolism within the past two years
- Comorbidity that may influence the immune system
- Life expectancy of less than 30 days
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Systemic corticosteroid groupTreatment being tested
Patients will receive Oral prednisone 40mg/day for five consecutive days in addition to standard treatment during emergency admission or hospitalization.
Treatment: Prednisone
- Control groupPlacebo, for comparison
Participating patients will receive an oral placebo of 40mg/day for five consecutive days in addition to standard treatment.
Treatment: Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Multicenter Double-blind Randomized Controlled Trial of Systemic Corticosteroid Therapy in AECOPD Patients Admitted to Hospital With Higher Blood Eosinophil Levels
- Publications
- Record updated
- 28 August 2024