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TerminatedNCT05059873Updated Aug 28, 2024

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

A Phase 4 interventional study of Prednisone and Placebo in Acute Exacerbation of COPD, Corticosteroid and Morality, sponsored by Capital Medical University. Terminated at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-28.

Sponsored by Capital Medical University · Phase 4, Interventional, and Treatment

Why this study was terminated
Difficulty in recruiting subjects
Phase
Phase 4
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 11 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
11 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugPrednisone

    Oral prednisone 40mg/day for five consecutive days

  • DrugPlacebo

    Oral placebo of 40mg/day for five consecutive days

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days

Secondary outcomes

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

    Collect during index hospitalization.

    Time frame: 14 days

  2. Requiring or transferring to ICU during the index hospitalization

    Collect during index hospitalization.

    Time frame: 14 days

  3. Length of index hospitalization longer than 14 days

    Collect during index hospitalization.

    Time frame: 14 days

  4. Death during the index hospitalization or within 30 days after discharge

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

    Time frame: 30 days after discahrge

  5. Readmission with acute exacerbations of COPD within 30 days after discharge

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

    Time frame: 30 days after discahrge

  6. All-cause mortality within 90 days after discharge

    Collect during 90-day follow-up.

    Time frame: 90 days after discahrge

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

    Collect during 90-day follow-up.

    Time frame: 90 days after discahrge

  8. Time to readmission of AECOPD within 90 days after discharge

    Collect during 90-day follow-up.

    Time frame: 90 days after discharge

  9. Severer infection or development of pneumonia during hospitalization

    Collect during index hospitalization.

    Time frame: 14 days

  10. 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.

    Time frame: 90 days

  11. 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.

    Time frame: 90 days

  12. 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.

    Time frame: 90 days

  13. 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.

    Time frame: 90 days

  14. 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.

    Time frame: 90 days

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

    Collect during huopitalization and 90-day follow-up.

    Time frame: 90 days

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

    Collect during 90-day follow-up by patients.

    Time frame: 90 days after discharge

  17. Length of hospital stay during hospitalization

    Collect during huopitalization

    Time frame: 14 days

07

Study locations

1 site
  • Beijing Chao-Yang Hospital
    Beijing, Beijing 100020, China
08

References and documents

Publications

  • Labaki WW, Rosenberg SR. Chronic Obstructive Pulmonary Disease. Ann Intern Med. 2020 Aug 4;173(3):ITC17-ITC32. doi: 10.7326/AITC202008040. PubMed 32745458 ↗
  • Duffy SP, Criner GJ. Chronic Obstructive Pulmonary Disease: Evaluation and Management. Med Clin North Am. 2019 May;103(3):453-461. doi: 10.1016/j.mcna.2018.12.005. Epub 2019 Mar 14. PubMed 30955513 ↗
  • Sivapalan P, Lapperre TS, Janner J, Laub RR, Moberg M, Bech CS, Eklof J, Holm FS, Armbruster K, Sivapalan P, Mosbech C, Ali AKM, Seersholm N, Wilcke JT, Brondum E, Sonne TP, Ronholt F, Andreassen HF, Ulrik CS, Vestbo J, Jensen JS. Eosinophil-guided corticosteroid therapy in patients admitted to hospital with COPD exacerbation (CORTICO-COP): a multicentre, randomised, controlled, open-label, non-inferiority trial. Lancet Respir Med. 2019 Aug;7(8):699-709. doi: 10.1016/S2213-2600(19)30176-6. Epub 2019 May 20. PubMed 31122894 ↗
  • Seemungal TA, Donaldson GC, Paul EA, Bestall JC, Jeffries DJ, Wedzicha JA. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1998 May;157(5 Pt 1):1418-22. doi: 10.1164/ajrccm.157.5.9709032. PubMed 9603117 ↗
  • Wedzicha JA, Singh R, Mackay AJ. Acute COPD exacerbations. Clin Chest Med. 2014 Mar;35(1):157-63. doi: 10.1016/j.ccm.2013.11.001. PubMed 24507843 ↗
  • Bafadhel M, Greening NJ, Harvey-Dunstan TC, Williams JE, Morgan MD, Brightling CE, Hussain SF, Pavord ID, Singh SJ, Steiner MC. Blood Eosinophils and Outcomes in Severe Hospitalized Exacerbations of COPD. Chest. 2016 Aug;150(2):320-8. doi: 10.1016/j.chest.2016.01.026. Epub 2016 Feb 3. PubMed 26851799 ↗
  • Cui Y, Zhan Z, Zeng Z, Huang K, Liang C, Mao X, Zhang Y, Ren X, Yang T, Chen Y. Blood Eosinophils and Clinical Outcomes in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Propensity Score Matching Analysis of Real-World Data in China. Front Med (Lausanne). 2021 Jun 9;8:653777. doi: 10.3389/fmed.2021.653777. eCollection 2021. PubMed 34179040 ↗
  • Ko FWS, Chan KP, Ngai J, Ng SS, Yip WH, Ip A, Chan TO, Hui DSC. Blood eosinophil count as a predictor of hospital length of stay in COPD exacerbations. Respirology. 2020 Mar;25(3):259-266. doi: 10.1111/resp.13660. Epub 2019 Aug 6. PubMed 31385389 ↗

Individual participant data

Plan to share: Yes — 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

Supporting information: Study protocol, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05059873
Lead 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, Bejing INFI-SAGACITY TECHNOLOGY CO., LTD, Chinese People's Liberation Army of China General Hospital, Beijing Yanhua Hospital, Peking University Shougang Hospital, The First Hospital of Fangshan District, Liangxiang Hospital, Beijing Huairou Hospital
Responsible party
Zhaohui Tong (Derictor of Beijing Institute of Respiratory Medicine and Vice president of Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China, Beijing Chao Yang Hospital) — Principal investigator
First posted
Sep 28, 2021
Start date
Mar 5, 2023
Primary completion
Apr 30, 2024
Completion
May 31, 2024
Last update
Aug 28, 2024

Study contacts

Tong Zhaohui, PhD
study chair · Beijing Chao Yang Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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