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Relationship Between Plasma Metabolome and the Efficacy of Systemic Glucocorticoid in AECOPD

Relationship Between Plasma Metabolome and the Efficacy of Systemic Glucocorticoid in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04710849
Enrollment
100
Registered
2021-01-15
Start date
2021-02-01
Completion date
2024-06-01
Last updated
2021-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, COPD Exacerbation Acute

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTSerum metabolic markers

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.

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients who meet the diagnostic criteria for acute exacerbation of chronic obstructive pulmonary disease in GOLD 2016 and require hospitalization.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Metabolic markers related to systemic glucocorticoid therapy1 yearThrough 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.

Secondary

MeasureTime frameDescription
Time from discharge to the next exacerbation1 yearThe time interval from the patient's discharge from the hospital to the next acute exacerbation of chronic obstructive pulmonary disease
Side effects of glucocorticoid therapy1 yearAny side effects related to glucocorticoid therapy, including osteoporosis, hyperglycemia, infection, etc.
Mortality within 1 year1 yearThe mortality rate of the patients within 1 year after enrollment, including overall mortality and COPD-related mortality
Length of hospital stay1 yearThe time interval from admission to discharge of the patient this time
mMRC score1 yearEvaluate the severity of dyspnea through a modified version of the British Medical Research Council Respiratory Questionnaire (mMRC)
CAT score1 yearEvaluate the severity of dyspnea through the COPD assessment Test questionnaire (CAT)
Changes in pulmonary function1 yearVentilation function and changes indicated by the patient's pulmonary function test
Acute exacerbation frequency1 yearThe number of acute exacerbations of chronic obstructive pulmonary disease in the one year follow-up after enrollment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026