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

Sponsor

Peking University Third Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04964037

Collaborator

(none)

120

Enrollment

14.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Other: No intervention

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 Design

Study Type:

Observational

Actual Enrollment :

120 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Analysis of Relationship Between Metabolic Biomarkers and Efficacy of Systemic Glucocorticoid in Acute Exacerbation of COPD

Actual Study Start Date :

Jan 2, 2017

Actual Primary Completion Date :

Mar 22, 2018

Actual Study Completion Date :

Mar 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Treatment success group No intervention	Other: No intervention No intervention
Treatment failure group No intervention	Other: No intervention No intervention

Arm

Intervention/Treatment

Treatment success group

No intervention

Other: No intervention

No intervention

Treatment failure group

No intervention

Other: No intervention

No intervention

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Liang Ying, Peking University Third Hospital, Peking University Third Hospital

ClinicalTrials.gov Identifier:

NCT04964037

Other Study ID Numbers:

LM2018024

First Posted:

Jul 15, 2021

Last Update Posted:

Jul 15, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Jul 15, 2021