Acute Exacerbation of COPDPhase 4NCT05059873
Treatment Efficacy of Systemic Corticosteroids in AECOPD Patients With Higher Blood Eosinophil Levels
A Phase 4 study testing Prednisone in people with Acute Exacerbation of COPD and Corticosteroid, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Acute Exacerbation of COPD, Corticosteroid, Morality
- What is being tested?
- Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2023to 31 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Acute Exacerbation of COPD, Corticosteroid, Morality, Lung Diseases, Obstructive, Blood Eosinophil Count, COPD
- Being tested
- Prednisone, Placebo
- Keywords
- Treatment failure rates, Chronic Obstructive Pulmonary Disease, Randomized Controlled Trial, Mortality, Corticosteroid, Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Oral prednisone 40mg/day for five consecutive days
PlaceboDrug
Oral placebo of 40mg/day for five consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Systemic corticosteroid group | Experimental | Patients will receive Oral prednisone 40mg/day for five consecutive days in addition to standard treatment during emergency admission or hospitalization. Receives: Drug: Prednisone |
| Control group | Placebo comparator | Participating patients will receive an oral placebo of 40mg/day for five consecutive days in addition to standard treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (17)
Requiring or receiving invasive or non-invasive MV during the index hospitalization
Collect during index hospitalization.
Measured: 14 days
Requiring or transferring to ICU during the index hospitalization
Collect during index hospitalization.
Measured: 14 days
Length of index hospitalization longer than 14 days
Collect during index hospitalization.
Measured: 14 days
Death during the index hospitalization or within 30 days after discharge
Collect during index hospitalization and 30-day follow-up.
Measured: 30 days after discahrge
Readmission with acute exacerbations of COPD within 30 days after discharge
Collect during index hospitalization and 30-day follow-up.
Measured: 30 days after discahrge
All-cause mortality within 90 days after discharge
Collect during 90-day follow-up.
Measured: 90 days after discahrge
Readmission rates of AECOPD at 60-day and 90-day follow-ups
Collect during 90-day follow-up.
Measured: 90 days after discahrge
Time to readmission of AECOPD within 90 days after discharge
Collect during 90-day follow-up.
Measured: 90 days after discharge
Severer infection or development of pneumonia during hospitalization
Collect during index hospitalization.
Measured: 14 days
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.
Measured: 90 days
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.
Measured: 90 days
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.
Measured: 90 days
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.
Measured: 90 days
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.
Measured: 90 days
Changes in the scores of Transition Dyspnea Index between index hospitalization and 90-day follow-up
Collect during huopitalization and 90-day follow-up.
Measured: 90 days
Changes in the scores of COPD Exacerbation Recognition Tool during 90-day follow-up
Collect during 90-day follow-up by patients.
Measured: 90 days after discharge
Length of hospital stay during hospitalization
Collect during huopitalization
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start5 Mar 2023
- Primary completion30 Apr 2024
- Study completion31 May 2024
Why it stopped: Difficulty in recruiting subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute Exacerbation of COPDStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Zhaohui Tong, Beijing Chao Yang Hospital
- Investigators
- Tong Zhaohui, PhD, Study chair, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059873
- Sponsor's protocol ID
- Z201100005520029
- Status last verified
- Aug 2024
- First submitted
- 18 Sep 2021
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Labaki WW, Rosenberg SR. Chronic Obstructive Pulmonary Disease. Ann Intern Med. 2020 Aug 4;173(3):ITC17-ITC32. doi: 10.7326/AITC202008040.
PubMed 32745458Duffy 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 30955513Sivapalan 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 31122894Seemungal 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 9603117Wedzicha 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 24507843Bafadhel 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 26851799Cui 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 34179040Ko 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 31385389Liang L, Lin Y, Feng L, Shao S, Cao S, Rong H, Chu S, Xie W, Cai S, Wang J, Tong Z. 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. BMJ Open. 2023 May 29;13(5):e066354. doi: 10.1136/bmjopen-2022-066354.
PubMed 37247957
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Double-blind Randomized Controlled Trial of Systemic Corticosteroid Therapy in AECOPD Patients Admitted to Hospital With Higher Blood Eosinophil Levels
- ClinicalTrials.gov ID
- NCT05059873
- Acronym / sponsor ID
- Z201100005520029
- Conditions
- Acute Exacerbation of COPD, Corticosteroid, Morality, Lung Diseases, Obstructive, Blood Eosinophil Count, COPD
- Keywords
- Treatment failure rates, Chronic Obstructive Pulmonary Disease, Randomized Controlled Trial, Mortality, Corticosteroid, Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting subjects
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- 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
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic corticosteroid group | Experimental | Drug: PrednisonePatients will receive Oral prednisone 40mg/day for five consecutive days in addition to standard treatment during emergency admission or hospitalization. |
| Control group | Placebo comparator | Drug: PlaceboParticipating patients will receive an oral placebo of 40mg/day for five consecutive days in addition to standard treatment. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoneOral prednisone 40mg/day for five consecutive days | Drug | Systemic corticosteroid group |
| PlaceboOral placebo of 40mg/day for five consecutive days | Drug | Control group |
Primary outcome
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.
17 secondary outcomes
Requiring or receiving invasive or non-invasive MV during the index hospitalization
Time frame: 14 days
Requiring or transferring to ICU during the index hospitalization
Time frame: 14 days
Length of index hospitalization longer than 14 days
Time frame: 14 days
Death during the index hospitalization or within 30 days after discharge
Time frame: 30 days after discahrge
Readmission with acute exacerbations of COPD within 30 days after discharge
Time frame: 30 days after discahrge
All-cause mortality within 90 days after discharge
Time frame: 90 days after discahrge
Readmission rates of AECOPD at 60-day and 90-day follow-ups
Time frame: 90 days after discahrge
Time to readmission of AECOPD within 90 days after discharge
Time frame: 90 days after discharge
Severer infection or development of pneumonia during hospitalization
Time frame: 14 days
Changes in the scores of Hospital Anxiety and Depression Scale between index hospitalization and 90-day follow-up
Time frame: 90 days
Changes in the scores of St. George's Respiratory Questionnaire between index hospitalization and 90-day follow-up
Time frame: 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
Changes in the scores of modified Medical Research Council Dyspnoea Scale between index hospitalization and 90-day follow-up
Time frame: 90 days
Changes in the scores of COPD Assessment Test between index hospitalization and 90-day follow-up
Time frame: 90 days
Changes in the scores of Transition Dyspnea Index between index hospitalization and 90-day follow-up
Time frame: 90 days
Changes in the scores of COPD Exacerbation Recognition Tool during 90-day follow-up
Time frame: 90 days after discharge
Length of hospital stay during hospitalization
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Difficulty in recruiting subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Background: PubMed 32745458Labaki WW, Rosenberg SR. Chronic Obstructive Pulmonary Disease. Ann Intern Med. 2020 Aug 4;173(3):ITC17-ITC32. doi: 10.7326/AITC202008040.
- Background: PubMed 30955513Duffy 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.
- Background: PubMed 31122894Sivapalan 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.
- Background: PubMed 9603117Seemungal 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.
- Background: PubMed 24507843Wedzicha 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.
- Background: PubMed 26851799Bafadhel 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.
- Background: PubMed 34179040Cui 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.
- Background: PubMed 31385389Ko 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.
- Derived from this study: PubMed 37247957Liang L, Lin Y, Feng L, Shao S, Cao S, Rong H, Chu S, Xie W, Cai S, Wang J, Tong Z. 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. BMJ Open. 2023 May 29;13(5):e066354. doi: 10.1136/bmjopen-2022-066354.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tong Zhaohui, PhD study chair
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone in people with Acute Exacerbation of COPD and Corticosteroid, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty in recruiting subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure rates (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05059873, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.