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

NCT04964037 | Completed

• 1 other identifier: LM2018024
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Serum metabolic biomarkers

  Liquid chromatography / mass spectrometry (LC-MS) was used to analyze the metabolites in AECOPD patients.

  Through study completion, an average of 10 days

Study Arms (2)

Treatment success group

No intervention

Other: No intervention

Treatment failure group

No intervention

Other: No intervention

Interventions

No intervention OTHER

No intervention

Treatment failure group; Treatment success group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum sample was obtained before glucocorticoid was given to the subject.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peking University Third Hospital

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 15, 2021
• Study Start: January 2, 2017
• Primary Completion: March 22, 2018
• Study Completion: March 30, 2018
• Last Updated: July 15, 2021

Record last verified: 2021-07