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

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ClinicalTrials.gov Identifier: NCT05059873
Recruitment Status : Not yet recruiting
First Posted : September 28, 2021
Last Update Posted : July 7, 2022
Sponsor:
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
Information provided by (Responsible Party):
Zhaohui Tong, Beijing Chao Yang Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Exacerbation of COPD Corticosteroid Morality Lung Diseases, Obstructive Blood Eosinophil Count COPD Pulmonary Disease, Chronic Obstructive Drug: Prednisone Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter Double-blind Randomized Controlled Trial of Systemic Corticosteroid Therapy in AECOPD Patients Admitted to Hospital With Higher Blood Eosinophil Levels
Estimated Study Start Date : October 10, 2022
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : March 31, 2024


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Treatment failure rates [ Time Frame: 30 days ]
    Collect during index hospitalization and within 30 days after discharge.


Secondary Outcome Measures :
  1. Admission to ICU rates during index hospitalization [ Time Frame: 14 days ]
    Collect during index hospitalization.

  2. Requiring or receiving invasive or non-invasive MV rates during index hospitalization [ Time Frame: 14 days ]
    Collect during index hospitalization.

  3. All-cause mortality during index hospitalization and within 90 days after discharge [ Time Frame: 90 days ]
    Collect during index hospitalization and 90-day follow-up.

  4. The length of hospital stay during index hospitalization [ Time Frame: 14 days ]
    Collect during index hospitalization.

  5. Readmission rates of AECOPD at 30-day, 60-day, and 90-day follow-ups [ Time Frame: 90 days ]
    Collect during 90-day follow-up.

  6. Time to readmission of AECOPD within 90 days [ Time Frame: 90 days ]
    Collect during 90-day follow-up.

  7. Changes in FEV1 between index hospitalization and 90-day follow-up [ Time Frame: 90 days ]
    Collect during 90-day follow-up.

  8. 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 90-day follow-up. The minimum and maximum values are 0 and 100, respectively. Higher scores mean a worse outcome.

  9. 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.

  10. 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 0 and 42, respectively. Higher scores mean a worse outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05059873


Contacts
Layout table for location contacts
Contact: Rong Hengmo, PhD +8615810271669 ronghengmo@sina.com

Sponsors and Collaborators
Capital Medical University
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
Investigators
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Study Chair: Tong Zhaohui, PhD Beijing Chao Yang Hospital
Additional Information:
Publications:

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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
ClinicalTrials.gov Identifier: NCT05059873    
Other Study ID Numbers: Z201100005520029
First Posted: September 28, 2021    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhaohui Tong, Beijing Chao Yang Hospital:
Treatment failure rates
Chronic Obstructive Pulmonary Disease
Randomized Controlled Trial
Mortality
Corticosteroid
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents