COPDNCT04710849
Relationship Between Plasma Metabolome and the Efficacy of Systemic Glucocorticoid in AECOPD
An observational study of COPD and COPD Exacerbation Acute, run by Peking University Third Hospital at 1 site in China.
Trial summary
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) significantly increases the mortality of the patients with COPD. Guidelines have recommended systemic glucocorticoid as regular treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, COPD Exacerbation Acute
- What is being tested?
- Serum metabolic markers
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 1 Jun 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A prospective study was conducted to recruit consecutive patients from January 1, 2020 to January 1, 2021 who were hospitalized in the Department of Respiratory and Critical Care Medicine in Peking University Third Hospital and met the diagnostic criteria of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in Global Initiative for Chronic Obstructive Lung Diseas 2016 (GOLD 2016).
Who may be able to join
- Patients who meet the diagnostic criteria for acute exacerbation of chronic obstructive pulmonary disease in GOLD 2016 and require hospitalization.
Who cannot join
- Bronchial asthma, bronchiectasis and other airflow obstructive diseases;
- Combined with community-acquired pneumonia, hospital-acquired pneumonia or aspiration pneumonia;
- Combined with severe liver and kidney insufficiency;
- Malignant tumor;
- Immune deficiency due to chemotherapy or HIV infection;
- Received systemic hormone therapy due to acute exacerbation of chronic obstructive pulmonary disease within 1 month before this admission;
- Severe trauma or stress, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100191
Qiu-Yu Li, MD, 15901118991, liqiuyu19871011@foxmail.com
Zhuo-Yu An, MD, 15010638916, anzhuoyu@pku.edu.cn
About this study
Official title: Relationship Between Plasma Metabolome and the Efficacy of Systemic Glucocorticoid in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) significantly increases the mortality of the patients with COPD. Guidelines have recommended systemic glucocorticoid as regular treatment. Recently, evidences have shown that systemic glucocorticoid cannot not be benefit to all of the patients with AECOPD. Thus the problem that how the clinicians can screen the patients who can benefit from systemic glucocorticoid needs to be solved urgently.
Read the detailed description
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) significantly increases the mortality of the patients with COPD. Guidelines have recommended systemic glucocorticoid as regular treatment. Recently, evidences have shown that systemic glucocorticoid cannot not be benefit to all of the patients with AECOPD. Thus the problem that how the clinicians can screen the patients who can benefit from systemic glucocorticoid needs to be solved urgently. A previous study found that plasma metabolome changed significantly after dexamethasone treatment in health participants. Furthermore, inter-person variability was high and remained uninfluenced by treatment, suggesting the potential of metabolomics for predicting the efficacy and side effects of systemic glucocorticoid. Our previous study found that serum metabolites profile in COPD patients differed from that in controls. Therefore, the investigators hypothesized that metabolome changes in patients with AECOPD may be associated with the efficacy of systemic glucocorticoid. In this study, the investigators will utilize ultraperformance liquid chromatography / mass spectrometry (LC-MS) and gas chromatography / mass spectrometry (GC-MS) methods for analysis of the metabolites in AECOPD patients and compare the metabolites profiles between patients with systemic glucocorticoid treatment success and treatment failure. The investigators aim to detect the metabolic biomarkers and metabolic pathways which are related to efficacy of systemic glucocorticoid and contribute to the precise treatment of COPD.
- Conditions
- COPD, COPD Exacerbation Acute
- Being tested
- Serum metabolic markers
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum metabolic markersDiagnostic test
Also called Metbolomics
Ultraperformance liquid chromatography / mass spectrometry (LC-MS) and gas chromatography / mass spectrometry (GC-MS) methods for analysis of the metabolites in AECOPD patients and compare the metabolites profiles between patients with systemic glucocorticoid treatment success and treatment failure.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Failure Group | The diagnostic criteria of AECOPD is defined in global initiative for chronic obstructive lung disease (GOLD 2016). According to the efficacy of systemic hormone therapy during hospitalization, they were divided into treatment success group and treatment failure group. Definition of systemic glucocorticoid treatment failure during hospitalization is (Reference: Crisafulli E, Torres A, Huerta A, et al. COPD, 2016, 13(1): 82-92): The following occurs from the 2nd to the 7th day after admission Situation: ①Need to receive mechanical ventilation treatment or need to be admitted to the ICU due to illness; ②72 hours after the initial anti-infective treatment, clinical signs of infection persist and need to change antibiotic treatment; ③Death from any cause. Receives: Diagnostic Test: Serum metabolic markers | |
| Treatment Success Group | The diagnostic criteria of AECOPD is defined in global initiative for chronic obstructive lung disease (GOLD 2016). According to the efficacy of systemic hormone therapy during hospitalization, they were divided into treatment success group and treatment failure group. The treatment success group was defined as not meeting any of the following conditions for failure of systemic hormone therapy during hospitalization (reference: Crisafulli E, Torres A, Huerta A, et al. COPD, 2016, 13(1): 82-92): ①Need to receive mechanical ventilation treatment or need to be admitted to the ICU due to illness; ②72 hours after the initial anti-infective treatment, clinical signs of infection persist and need to change antibiotic treatment; ③Death from any cause. Receives: Diagnostic Test: Serum metabolic markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic markers related to systemic glucocorticoid therapy
Through metabolomics research methods such as liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry, study the metabolic marker group profile of patients with acute exacerbation of COPD before receiving systemic glucocorticoid therapy, and look for possible systemic metabolic markers related to the short-term and long-term effects of glucocorticoids.
Measured: 1 year
Secondary outcomes (8)
Length of hospital stay
The time interval from admission to discharge of the patient this time
Measured: 1 year
Time from discharge to the next exacerbation
The time interval from the patient's discharge from the hospital to the next acute exacerbation of chronic obstructive pulmonary disease
Measured: 1 year
Side effects of glucocorticoid therapy
Any side effects related to glucocorticoid therapy, including osteoporosis, hyperglycemia, infection, etc.
Measured: 1 year
Mortality within 1 year
The mortality rate of the patients within 1 year after enrollment, including overall mortality and COPD-related mortality
Measured: 1 year
Acute exacerbation frequency
The number of acute exacerbations of chronic obstructive pulmonary disease in the one year follow-up after enrollment
Measured: 1 year
mMRC score
Evaluate the severity of dyspnea through a modified version of the British Medical Research Council Respiratory Questionnaire (mMRC)
Measured: 1 year
CAT score
Evaluate the severity of dyspnea through the COPD assessment Test questionnaire (CAT)
Measured: 1 year
Changes in pulmonary function
Ventilation function and changes indicated by the patient's pulmonary function test
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Feb 2021 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, li qiuyu, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710849
- Sponsor's protocol ID
- PUTH-COPD001
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li QY, An ZY, Pan ZH, Qi RY. Rationale and design of REGULATE: an observational study protocol for relationship between plasma metabolome and the efficacy of systemic glucocorticoid in acute exacerbation of chronic obstructive pulmonary disease. BMC Pulm Med. 2021 Jul 28;21(1):250. doi: 10.1186/s12890-021-01614-3.
PubMed 34320980
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Plasma Metabolome and the Efficacy of Systemic Glucocorticoid in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04710849
- Acronym / sponsor ID
- PUTH-COPD001
- Conditions
- COPD, COPD Exacerbation Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 15 Jan 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.
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) significantly increases the mortality of the patients with COPD. Guidelines have recommended systemic glucocorticoid as regular treatment. Recently, evidences have shown that systemic glucocorticoid cannot not be benefit to all of the patients with AECOPD. Thus the problem that how the clinicians can screen the patients who can benefit from systemic glucocorticoid needs to be solved urgently.
Detailed description
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) significantly increases the mortality of the patients with COPD. Guidelines have recommended systemic glucocorticoid as regular treatment. Recently, evidences have shown that systemic glucocorticoid cannot not be benefit to all of the patients with AECOPD. Thus the problem that how the clinicians can screen the patients who can benefit from systemic glucocorticoid needs to be solved urgently. A previous study found that plasma metabolome changed significantly after dexamethasone treatment in health participants. Furthermore, inter-person variability was high and remained uninfluenced by treatment, suggesting the potential of metabolomics for predicting the efficacy and side effects of systemic glucocorticoid. Our previous study found that serum metabolites profile in COPD patients differed from that in controls. Therefore, the investigators hypothesized that metabolome changes in patients with AECOPD may be associated with the efficacy of systemic glucocorticoid. In this study, the investigators will utilize ultraperformance liquid chromatography / mass spectrometry (LC-MS) and gas chromatography / mass spectrometry (GC-MS) methods for analysis of the metabolites in AECOPD patients and compare the metabolites profiles between patients with systemic glucocorticoid treatment success and treatment failure. The investigators aim to detect the metabolic biomarkers and metabolic pathways which are related to efficacy of systemic glucocorticoid and contribute to the precise treatment of COPD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Failure Group | – | Diagnostic Test: Serum metabolic markersThe diagnostic criteria of AECOPD is defined in global initiative for chronic obstructive lung disease (GOLD 2016). According to the efficacy of systemic hormone therapy during hospitalization, they were divided into treatment success group and treatment failure group. Definition of systemic glucocorticoid treatment failure during hospitalization is (Reference: Crisafulli E, Torres A, Huerta A, et al. COPD, 2016, 13(1): 82-92): The following occurs from the 2nd to the 7th day after admission Situation: ①Need to receive mechanical ventilation treatment or need to be admitted to the ICU due to illness; ②72 hours after the initial anti-infective treatment, clinical signs of infection persist and need to change antibiotic treatment; ③Death from any cause. |
| Treatment Success Group | – | Diagnostic Test: Serum metabolic markersThe diagnostic criteria of AECOPD is defined in global initiative for chronic obstructive lung disease (GOLD 2016). According to the efficacy of systemic hormone therapy during hospitalization, they were divided into treatment success group and treatment failure group. The treatment success group was defined as not meeting any of the following conditions for failure of systemic hormone therapy during hospitalization (reference: Crisafulli E, Torres A, Huerta A, et al. COPD, 2016, 13(1): 82-92): ①Need to receive mechanical ventilation treatment or need to be admitted to the ICU due to illness; ②72 hours after the initial anti-infective treatment, clinical signs of infection persist and need to change antibiotic treatment; ③Death from any cause. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A prospective study was conducted to recruit consecutive patients from January 1, 2020 to January 1, 2021 who were hospitalized in the Department of Respiratory and Critical Care Medicine in Peking University Third Hospital and met the diagnostic criteria of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in Global Initiative for Chronic Obstructive Lung Diseas 2016 (GOLD 2016).
Key inclusion criteria (1 listed)
- Patients who meet the diagnostic criteria for acute exacerbation of chronic obstructive pulmonary disease in GOLD 2016 and require hospitalization.
Key exclusion criteria (7 listed)
- Bronchial asthma, bronchiectasis and other airflow obstructive diseases;
- Combined with community-acquired pneumonia, hospital-acquired pneumonia or aspiration pneumonia;
- Combined with severe liver and kidney insufficiency;
- Malignant tumor;
- Immune deficiency due to chemotherapy or HIV infection;
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 |
|---|---|---|
| Serum metabolic markersAlso: MetbolomicsUltraperformance liquid chromatography / mass spectrometry (LC-MS) and gas chromatography / mass spectrometry (GC-MS) methods for analysis of the metabolites in AECOPD patients and compare the metabolites profiles between patients with systemic glucocorticoid treatment success and treatment failure. | Diagnostic test | Treatment Failure Group, Treatment Success Group |
Primary outcome
Metabolic markers related to systemic glucocorticoid therapy
Time frame: 1 year
Through metabolomics research methods such as liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry, study the metabolic marker group profile of patients with acute exacerbation of COPD before receiving systemic glucocorticoid therapy, and look for possible systemic metabolic markers related to the short-term and long-term effects of glucocorticoids.
8 secondary outcomes
Length of hospital stay
Time frame: 1 year
Time from discharge to the next exacerbation
Time frame: 1 year
Side effects of glucocorticoid therapy
Time frame: 1 year
Mortality within 1 year
Time frame: 1 year
Acute exacerbation frequency
Time frame: 1 year
mMRC score
Time frame: 1 year
CAT score
Time frame: 1 year
Changes in pulmonary function
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Derived from this study: PubMed 34320980Li QY, An ZY, Pan ZH, Qi RY. Rationale and design of REGULATE: an observational study protocol for relationship between plasma metabolome and the efficacy of systemic glucocorticoid in acute exacerbation of chronic obstructive pulmonary disease. BMC Pulm Med. 2021 Jul 28;21(1):250. doi: 10.1186/s12890-021-01614-3.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and COPD Exacerbation Acute, run by Peking University Third Hospital 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Jan 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic markers related to systemic glucocorticoid therapy (time frame: 1 year). 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 NCT04710849, which also lists 1 linked publication.
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 15 Jan 2021.