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

Primary Purpose

Acute Exacerbation of COPD, Corticosteroid, Morality

Status

Not yet recruiting

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Prednisone

Placebo

About this trial

This is an interventional treatment trial for Acute Exacerbation of COPD focused on measuring Treatment failure rates, Chronic Obstructive Pulmonary Disease, Randomized Controlled Trial, Mortality, Corticosteroid, Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

Admission due to other diseases (pneumonia, pneumothorax, pulmonary interstitial disease, active tuberculosis or bronchiectasis, ect);
Regular use of glucocorticoid ≥3 months;
Received prednisone ≥ 60 mg in the past three days (or equivalent doses of other corticosteroid);
Allergic or intolerant to corticosteroid;
Participating in or completed another drug trial within 90 days;
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;
Myocardial infarction, uncontrollable congestive heart failure or arrhythmia within the past four weeks;
Comorbidity that may influence the immune system;
Malignant tumor;
Neuromuscular disease affecting the respiratory system;
Systemic fungal infection;
Thoracotomy or bronchoscopic lung volume reduction surgery history;
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;
Life expectancy of less than 30 days.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Systemic corticosteroid group

Control group

Arm Description

Patients will receive Oral prednisone 40mg/day for five consecutive days in addition to standard treatment during emergency admission or hospitalization.

Participating patients will receive an oral placebo of 40mg/day for five consecutive days in addition to standard treatment.

Outcomes

Primary Outcome Measures

Treatment failure rates

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.

Secondary Outcome Measures

Requiring or receiving invasive or non-invasive MV during the index hospitalization

Collect during index hospitalization.

Requiring or transferring to ICU during the index hospitalization

Collect during index hospitalization.

Length of index hospitalization longer than 14 days

Collect during index hospitalization.

Death during the index hospitalization or within 30 days after discharge

Collect during index hospitalization and 30-day follow-up.

Readmission with acute exacerbations of COPD within 30 days after discharge

Collect during index hospitalization and 30-day follow-up.

All-cause mortality within 90 days after discharge

Collect during 90-day follow-up.

Readmission rates of AECOPD at 60-day and 90-day follow-ups

Collect during 90-day follow-up.

Time to readmission of AECOPD within 90 days after discharge

Collect during 90-day follow-up.

Severer infection or development of pneumonia during hospitalization

Collect during index hospitalization.

Changes in the scores of Hospital Anxiety and Depression Scale between index hospitalization and 90-day follow-up

Collect during 90-day follow-up. The minimum and maximum values are 14 and 70, respectively. Higher scores mean a worse outcome.

Changes in the scores of St. George's Respiratory Questionnaire between index hospitalization and 90-day follow-up

Collect during 90-day follow-up. The minimum and maximum values are 1 and 80, respectively. Higher scores mean a worse outcome.

Changes in the scores of exacerbations of chronic pulmonary disease tool between index hospitalization and 90-day follow-up

Collect during huopitalization and 90-day follow-up. The minimum and maximum values are 14 and 73, respectively. Higher scores mean a worse outcome.

Changes in the scores of modified Medical Research Council Dyspnoea Scale between index hospitalization and 90-day follow-up

Collect during huopitalization and 90-day follow-up. The minimum and maximum values are 1 and 5, respectively. Higher scores mean a worse outcome.

Changes in the scores of COPD Assessment Test between index hospitalization and 90-day follow-up

Collect during huopitalization and 90-day follow-up. The minimum and maximum values are 0 and 40, respectively. Higher scores mean a worse outcome.

Changes in the scores of Transition Dyspnea Index between index hospitalization and 90-day follow-up

Collect during huopitalization and 90-day follow-up.

Changes in the scores of COPD Exacerbation Recognition Tool during 90-day follow-up

Collect during 90-day follow-up by patients.

Length of hospital stay during hospitalization

Collect during huopitalization

Full Information

NCT ID

NCT05059873

First Posted

September 18, 2021

Last Updated

March 10, 2023

Sponsor

Capital Medical University

Collaborators

Peking University, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Xuanwu Hospital, Beijing, Beijing Anzhen Hospital, Beijing Tongren Hospital, Beijing Luhe Hospital, Emergency General Hospital, Beijing Jishuitan Hospital, Beijing Jingmei Group Hospital, Beijing Shijingshan Hospital, Bejing INFI-SAGACITY TECHNOLOGY CO., LTD, Chinese People's Liberation Army of China General Hospital, Beijing Yanhua Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05059873

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 5, 2023 (Anticipated)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Capital Medical University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Treatment failure rates, Chronic Obstructive Pulmonary Disease, Randomized Controlled Trial, Mortality, Corticosteroid, Acute Exacerbation of Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

456 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Systemic corticosteroid group

Arm Type

Experimental

Arm Description

Patients will receive Oral prednisone 40mg/day for five consecutive days in addition to standard treatment during emergency admission or hospitalization.

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Participating patients will receive an oral placebo of 40mg/day for five consecutive days in addition to standard treatment.

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

Oral prednisone 40mg/day for five consecutive days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral placebo of 40mg/day for five consecutive days

Primary Outcome Measure Information:

Title

Treatment failure rates

Description

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Requiring or receiving invasive or non-invasive MV during the index hospitalization

Description

Collect during index hospitalization.

Time Frame

14 days

Title

Requiring or transferring to ICU during the index hospitalization

Description

Collect during index hospitalization.

Time Frame

14 days

Title

Length of index hospitalization longer than 14 days

Description

Collect during index hospitalization.

Time Frame

14 days

Title

Death during the index hospitalization or within 30 days after discharge

Description

Collect during index hospitalization and 30-day follow-up.

Time Frame

30 days after discahrge

Title

Readmission with acute exacerbations of COPD within 30 days after discharge

Description

Collect during index hospitalization and 30-day follow-up.

Time Frame

30 days after discahrge

Title

All-cause mortality within 90 days after discharge

Description

Collect during 90-day follow-up.

Time Frame

90 days after discahrge

Title

Readmission rates of AECOPD at 60-day and 90-day follow-ups

Description

Collect during 90-day follow-up.

Time Frame

90 days after discahrge

Title

Time to readmission of AECOPD within 90 days after discharge

Description

Collect during 90-day follow-up.

Time Frame

90 days after discharge

Title

Severer infection or development of pneumonia during hospitalization

Description

Collect during index hospitalization.

Time Frame

14 days

Title

Changes in the scores of Hospital Anxiety and Depression Scale between index hospitalization and 90-day follow-up

Description

Collect during 90-day follow-up. The minimum and maximum values are 14 and 70, respectively. Higher scores mean a worse outcome.

Time Frame

90 days

Title

Changes in the scores of St. George's Respiratory Questionnaire between index hospitalization and 90-day follow-up

Description

Collect during 90-day follow-up. The minimum and maximum values are 1 and 80, respectively. Higher scores mean a worse outcome.

Time Frame

90 days

Title

Changes in the scores of exacerbations of chronic pulmonary disease tool between index hospitalization and 90-day follow-up

Description

Collect during huopitalization and 90-day follow-up. The minimum and maximum values are 14 and 73, respectively. Higher scores mean a worse outcome.

Time Frame

90 days

Title

Changes in the scores of modified Medical Research Council Dyspnoea Scale between index hospitalization and 90-day follow-up

Description

Collect during huopitalization and 90-day follow-up. The minimum and maximum values are 1 and 5, respectively. Higher scores mean a worse outcome.

Time Frame

90 days

Title

Changes in the scores of COPD Assessment Test between index hospitalization and 90-day follow-up

Description

Collect during huopitalization and 90-day follow-up. The minimum and maximum values are 0 and 40, respectively. Higher scores mean a worse outcome.

Time Frame

90 days

Title

Changes in the scores of Transition Dyspnea Index between index hospitalization and 90-day follow-up

Description

Collect during huopitalization and 90-day follow-up.

Time Frame

90 days

Title

Changes in the scores of COPD Exacerbation Recognition Tool during 90-day follow-up

Description

Collect during 90-day follow-up by patients.

Time Frame

90 days after discharge

Title

Length of hospital stay during hospitalization

Description

Collect during huopitalization

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Admission due to other diseases (pneumonia, pneumothorax, pulmonary interstitial disease, active tuberculosis or bronchiectasis, ect); Regular use of glucocorticoid ≥3 months; Received prednisone ≥ 60 mg in the past three days (or equivalent doses of other corticosteroid); Allergic or intolerant to corticosteroid; Participating in or completed another drug trial within 90 days; 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; Myocardial infarction, uncontrollable congestive heart failure or arrhythmia within the past four weeks; Comorbidity that may influence the immune system; Malignant tumor; Neuromuscular disease affecting the respiratory system; Systemic fungal infection; Thoracotomy or bronchoscopic lung volume reduction surgery history; 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; Life expectancy of less than 30 days.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rong Hengmo, PhD

Phone

+8615810271669

ronghengmo@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tong Zhaohui, PhD

Organizational Affiliation

Beijing Chao Yang Hospital

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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)

Citations:

PubMed Identifier

32745458

Citation

Labaki WW, Rosenberg SR. Chronic Obstructive Pulmonary Disease. Ann Intern Med. 2020 Aug 4;173(3):ITC17-ITC32. doi: 10.7326/AITC202008040.

Results Reference

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Citation

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Results Reference

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Citation

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Citation

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Links:

URL

http://rs.yiigle.com/CN131368201714/1000344.htm

Description

Chinese expert consensus on the diagnosis and treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) (updated version in 2017)

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

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