NCT05059873

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

Terminated Phase 4 Last updated 28 August 2024

What this trial tests

Phase 4 trial testing Prednisone in Acute Exacerbation of COPD in 11 participants. Terminated before completion.

Timeline

5 March 2023

Primary endpoint
30 April 2024

31 May 2024

Quick facts

Lead sponsor	Capital Medical University
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	11
Start date	5 March 2023
Primary completion	30 April 2024
Estimated completion	31 May 2024
Sites	1 location across China

Drugs / interventions tested

• Prednisone (prednisone) — full drug profile →
• Placebo

Conditions studied

• Acute Exacerbation of COPD — all drugs for Acute Exacerbation of COPD →
• Corticosteroid — all drugs for Corticosteroid →
• Morality — all drugs for Morality →
• Lung Diseases, Obstructive — all drugs for Lung Diseases, Obstructive →

Sponsor

Capital Medical University

Who can join

Adults 40 to 80, any sex, with Acute Exacerbation of COPD or Corticosteroid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Relationship of Fractional Exhaled Nitric Oxide in Patients with AECOPD.
   Xu X, Zhou L, Tong Z. · · 2023 · cited 4× · PMID 38146507 · DOI 10.2147/copd.s434040
2. Multicentre double-blind randomised controlled trial of systematic corticosteroid therapy in patients with acute exacerbations of chronic obstructive pulmonary disease admitted to hospital with higher eosinophil levels: the ECHO protocol.
   Liang L, Lin Y, Feng L, Shao S, et al · · 2023 · cited 4× · PMID 37247957 · DOI 10.1136/bmjopen-2022-066354
3. Time-Updated Phenotypic Guidance of Corticosteroids and Antibiotics in COPD: Rationale, Perspective and a Proposed Method.
   Jordan A, Sivapalan P, Rømer V, Jensen JU. · · 2023 · cited 4× · PMID 37239067 · DOI 10.3390/biomedicines11051395