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

NCT ID: NCT04964037

Last Updated: 2021-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-02

Study Completion Date

2018-03-30

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Treatment success group

No intervention

No intervention

Intervention Type OTHER

No intervention

Treatment failure group

No intervention

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Liang Ying

Peking University Third Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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LM2018024

Identifier Type: -

Identifier Source: org_study_id

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