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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04710849
• Other study ID #: PUTH-COPD001
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: January 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• COPD Exacerbation Acute

Intervention

Diagnostic Test:
• Serum 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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic markers related to systemic glucocorticoid therapy	Through 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.	1 year
Secondary	Length of hospital stay	The time interval from admission to discharge of the patient this time	1 year
Secondary	Time from discharge to the next exacerbation	The time interval from the patient's discharge from the hospital to the next acute exacerbation of chronic obstructive pulmonary disease	1 year
Secondary	Side effects of glucocorticoid therapy	Any side effects related to glucocorticoid therapy, including osteoporosis, hyperglycemia, infection, etc.	1 year
Secondary	Mortality within 1 year	The mortality rate of the patients within 1 year after enrollment, including overall mortality and COPD-related mortality	1 year
Secondary	Acute exacerbation frequency	The number of acute exacerbations of chronic obstructive pulmonary disease in the one year follow-up after enrollment	1 year
Secondary	mMRC score	Evaluate the severity of dyspnea through a modified version of the British Medical Research Council Respiratory Questionnaire (mMRC)	1 year
Secondary	CAT score	Evaluate the severity of dyspnea through the COPD assessment Test questionnaire (CAT)	1 year
Secondary	Changes in pulmonary function	Ventilation function and changes indicated by the patient's pulmonary function test	1 year