Clinical trial NCT04964037: Analysis of Relationship Between Metabolic Biomarkers and Efficacy of Glucocorticoid in AECOPD
Official title: Analysis of Relationship Between Metabolic Biomarkers and Efficacy of Systemic Glucocorticoid in Acute Exacerbation of COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutively recruited the patients admitted to the ward of Department of Respiratory and Critical Care Medicine due to COPD exacerbation from January 2017 to March 2018

Brief summary: Evidences have shown that systemic glucocorticoid cannot not be benefit to all of the patients with AECOPD. The problem that how the clinicians can screen the patients who can benefit from systemic glucocorticoid needs to be solved. Our previous study found that serum metabolites profile in COPD patients differed from that in controls. Therefore, we hypothesized that metabolome changes in patients with AECOPD may be associated with the efficacy of systemic glucocorticoid. In this study, we 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. We 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.

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, we hypothesized that metabolome changes in patients with AECOPD may be associated with the efficacy of systemic glucocorticoid. In this study, we 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. We 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.

Eligibility criteria: Inclusion Criteria:

* All the patients met the diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and had definite airflow limitation with a post-bronchodilator forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC)\<0.7.
* They were admitted to the ward of Department of Respiratory and Critical Care Medicine due to COPD exacerbation.

Exclusion Criteria:

* age \<40 years;
* subjects with airway diseases other than COPD;
* comunity acquired pneumonia;
* active tuberculosis;
* severe liver or renal dysfunction;
* malignancy;
* HIV infection or immunodeficiency;
* ever received glucocorticoid in the past month.

Primary outcomes:
measure: Serum metabolic biomarkers
timeFrame: Through study completion, an average of 10 days
Secondary outcomes:
Other outcomes:
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