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

August 27, 2024 updated by: Zhaohui Tong, Capital Medical University

A Multicenter Double-blind Randomized Controlled Trial of Systemic Corticosteroid Therapy in AECOPD Patients Admitted to Hospital With Higher Blood Eosinophil Levels

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Data about individual deidentified participants of this trial will be available from the corresponding author Zhaohui Tong (Email: tongzhaohuicy@sina.com) on reasonable request after the main results of the ECHO study have been published.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100020
        • Beijing Chao-Yang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Within 24 hours of admission;
  2. Aged between of 40 and 80 years old;
  3. 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);
  4. AECOPD diagnosis in accordance with the GOLD guideline (An acute worsening of respiratory symptoms that result in additional therapy)12;
  5. Current or former cigarette smokers (≥10 packs per year);
  6. Blood eosinophil count > 2% or >300 cells/μL tested within 24 hours of admission;
  7. Signed informed consent.

Exclusion Criteria:

  1. Admission due to other diseases (pneumonia, pneumothorax, pulmonary interstitial disease, active tuberculosis or bronchiectasis, ect);
  2. Regular use of glucocorticoid ≥3 months;
  3. Received prednisone ≥ 60 mg in the past three days (or equivalent doses of other corticosteroid);
  4. Allergic or intolerant to corticosteroid;
  5. Participating in or completed another drug trial within 90 days;
  6. Pregnancy or lactation;
  7. Severe COPD exacerbation requiring invasive mechanical ventilation (IMV) or transfer to ICU within 24 hours after emergency admission or hospitalization;
  8. With complications that may cause eosinophilia;
  9. Pulmonary embolism within the past two years;
  10. Myocardial infarction, uncontrollable congestive heart failure or arrhythmia within the past four weeks;
  11. Comorbidity that may influence the immune system;
  12. Malignant tumor;
  13. Neuromuscular disease affecting the respiratory system;
  14. Systemic fungal infection;
  15. Thoracotomy or bronchoscopic lung volume reduction surgery history;
  16. Adrenocortical insufficiency history;
  17. Diabetes mellitus with poor glycemic control;
  18. Uncontrollable severe psychiatric illnesses even with medication, cognitive impairment, and severe language difficulties;
  19. ALT ≥ 100U/L or AST ≥ 80U/L;
  20. Serum creatinine ≥ 162umol/L;
  21. Life expectancy of less than 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Systemic corticosteroid group
Patients will receive Oral prednisone 40mg/day for five consecutive days in addition to standard treatment during emergency admission or hospitalization.
Drug: Prednisone
Oral prednisone 40mg/day for five consecutive days
Placebo Comparator: Control group
Participating patients will receive an oral placebo of 40mg/day for five consecutive days in addition to standard treatment.
Drug: Placebo
Oral placebo of 40mg/day for five consecutive days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment failure rates
Time Frame: 30 days
Collect during index hospitalization and within 30 days after discharge. Treatment failure is defined as either one of events: a) requiring or receiving invasive or non-invasive MV during the index hospitalization; b) requiring or transferring to ICU during the index hospitalization; c) length of index hospitalization longer than 14 days; d) death during the index hospitalization or within 30 days after discharge; e) readmission with acute exacerbations of COPD within 30 days after discharge.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Requiring or receiving invasive or non-invasive MV during the index hospitalization
Time Frame: 14 days
Collect during index hospitalization.
14 days
Requiring or transferring to ICU during the index hospitalization
Time Frame: 14 days
Collect during index hospitalization.
14 days
Length of index hospitalization longer than 14 days
Time Frame: 14 days
Collect during index hospitalization.
14 days
Death during the index hospitalization or within 30 days after discharge
Time Frame: 30 days after discahrge
Collect during index hospitalization and 30-day follow-up.
30 days after discahrge
Readmission with acute exacerbations of COPD within 30 days after discharge
Time Frame: 30 days after discahrge
Collect during index hospitalization and 30-day follow-up.
30 days after discahrge
All-cause mortality within 90 days after discharge
Time Frame: 90 days after discahrge
Collect during 90-day follow-up.
90 days after discahrge
Readmission rates of AECOPD at 60-day and 90-day follow-ups
Time Frame: 90 days after discahrge
Collect during 90-day follow-up.
90 days after discahrge
Time to readmission of AECOPD within 90 days after discharge
Time Frame: 90 days after discharge
Collect during 90-day follow-up.
90 days after discharge
Severer infection or development of pneumonia during hospitalization
Time Frame: 14 days
Collect during index hospitalization.
14 days
Changes in the scores of Hospital Anxiety and Depression Scale between index hospitalization and 90-day follow-up
Time Frame: 90 days
Collect during 90-day follow-up. The minimum and maximum values are 14 and 70, respectively. Higher scores mean a worse outcome.
90 days
Changes in the scores of St. George's Respiratory Questionnaire between index hospitalization and 90-day follow-up
Time Frame: 90 days
Collect during 90-day follow-up. The minimum and maximum values are 1 and 80, respectively. Higher scores mean a worse outcome.
90 days
Changes in the scores of exacerbations of chronic pulmonary disease tool between index hospitalization and 90-day follow-up
Time Frame: 90 days
Collect during huopitalization and 90-day follow-up. The minimum and maximum values are 14 and 73, respectively. Higher scores mean a worse outcome.
90 days
Changes in the scores of modified Medical Research Council Dyspnoea Scale between index hospitalization and 90-day follow-up
Time Frame: 90 days
Collect during huopitalization and 90-day follow-up. The minimum and maximum values are 1 and 5, respectively. Higher scores mean a worse outcome.
90 days
Changes in the scores of COPD Assessment Test between index hospitalization and 90-day follow-up
Time Frame: 90 days
Collect during huopitalization and 90-day follow-up. The minimum and maximum values are 0 and 40, respectively. Higher scores mean a worse outcome.
90 days
Changes in the scores of Transition Dyspnea Index between index hospitalization and 90-day follow-up
Time Frame: 90 days
Collect during huopitalization and 90-day follow-up.
90 days
Changes in the scores of COPD Exacerbation Recognition Tool during 90-day follow-up
Time Frame: 90 days after discharge
Collect during 90-day follow-up by patients.
90 days after discharge
Length of hospital stay during hospitalization
Time Frame: 14 days
Collect during huopitalization
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Capital Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Xuanwu Hospital, Beijing
Peking University Shougang Hospital
Beijing Tongren Hospital
Beijing Anzhen Hospital
Beijing Jishuitan Hospital
Beijing Luhe Hospital
Beijing Huairou Hospital
Emergency General Hospital
Beijing Jingmei Group Hospital
Bejing INFI-SAGACITY TECHNOLOGY CO., LTD
Chinese People's Liberation Army of China General Hospital
Beijing Yanhua Hospital
The First Hospital of Fangshan District
Liangxiang Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Tong Zhaohui, PhD, Beijing Chao Yang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Z201100005520029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data about individual deidentified participants of this trial will be available from the corresponding author Zhaohui Tong (Email: tongzhaohuicy@sina.com) on reasonable request after the main results of the ECHO study have been published

IPD Sharing Time Frame

After the main results of the ECHO study have been published

IPD Sharing Access Criteria

Supporting information will be available from the corresponding author Zhaohui Tong (Email: tongzhaohuicy@sina.com)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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