Clinical trial NCT04710849: Relationship Between Plasma Metabolome and the Efficacy of Systemic Glucocorticoid in AECOPD
Official title: Relationship Between Plasma Metabolome and the Efficacy of Systemic Glucocorticoid in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
COPD Exacerbation Acute
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective study was conducted to recruit consecutive patients from January 1, 2020 to January 1, 2021 who were hospitalized in the Department of Respiratory and Critical Care Medicine in Peking University Third Hospital and met the diagnostic criteria of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in Global Initiative for Chronic Obstructive Lung Diseas 2016 (GOLD 2016).

Brief 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.

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, 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Metabolic markers related to systemic glucocorticoid therapy
timeFrame: 1 year
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 1 year
measure: Time from discharge to the next exacerbation
timeFrame: 1 year
measure: Side effects of glucocorticoid therapy
timeFrame: 1 year
measure: Mortality within 1 year
timeFrame: 1 year
measure: Acute exacerbation frequency
timeFrame: 1 year
measure: mMRC score
timeFrame: 1 year
measure: CAT score
timeFrame: 1 year
measure: Changes in pulmonary function
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References:
citation: Li QY, An ZY, Pan ZH, Qi RY. Rationale and design of REGULATE: an observational study protocol for relationship between plasma metabolome and the efficacy of systemic glucocorticoid in acute exacerbation of chronic obstructive pulmonary disease. BMC Pulm Med. 2021 Jul 28;21(1):250. doi: 10.1186/s12890-021-01614-3.