Analysis of Relationship Between Metabolic Biomarkers and Efficacy of Glucocorticoid in AECOPD

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: No intervention

• Registration Number: NCT04964037
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2017-01-02
• Primary Completion: 2018-03-22
• Study Completion: 2018-03-30
• Study First Submitted: 2021-06-29
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-07
• Last Update Submitted: 2021-07-07
• Study First Posted: 2021-07-15
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment failure group	No intervention	No intervention
Treatment success group	No intervention	No intervention

Primary Outcome Measures

Name	Time	Method
Serum metabolic biomarkers	Through study completion, an average of 10 days	Liquid chromatography / mass spectrometry (LC-MS) was used to analyze the metabolites in AECOPD patients.