Relationship Between Metabolic Profile and Clinical Phenotype in Chronic Obstructive Pulmonary Disease
Compartmental Analysis of Metabolite Profiles Associated With Disease Phenotype in Smokers With and Without Chronic Obstructive Pulmonary Disease
1 other identifier
observational
167
1 country
1
Brief Summary
Despite the high prevalence of chronic obstructive pulmonary disease (COPD), there continues to be a large gap in our understanding of disease pathogenesis and mechanisms accounting for large variability in disease phenotype. Untargeted metabolomics is an ideal approach to uncover the metabolic basis of disease, as well as discover unique drug target opportunities aimed at these nodal metabolic drivers of disease. There are very limited data from metabolomics studies from plasma/serum and exhaled breath condensate that suggest certain metabolic pathways or metabolites might predict the presence and/or severity of COPD phenotypes. Here, the investigators hope to generate comprehensive, compartment specific (blood and lung) metabolite profiles that will be correlated with various clinical phenotypes of COPD, using a complementary approach of untargeted nuclear magnetic resonance (NMR) and liquid chromatography (LC)- mass spectroscopy (MS) -based metabolomics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2017
CompletedFirst Submitted
Initial submission to the registry
October 10, 2017
CompletedFirst Posted
Study publicly available on registry
October 16, 2017
CompletedOctober 17, 2017
October 1, 2017
1.6 years
October 10, 2017
October 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metabolites that can predict the progress of lung function
The study is aimed to investigate the relationship between the metabolites and the progress of lung function in COPD
3 months
Secondary Outcomes (2)
Metabolites that can predict the severity of emphysema
3 months
Metabolites that are associated with inflammatory mediators
3 months
Study Arms (2)
COPD
The smokers who are diagnosed as chronic obstructive pulmonary disease according to GOLD guideline.
healthy control
The healthy controls without chronic obstructive pulmonary disease
Eligibility Criteria
Clinically stable patients with COPD and controls without COPD are enrolled.
You may qualify if:
- males aged 40-80;
- diagnosed with COPD according to the GOLD guidelines;
- clinically stable patients without medication changes or exacerbation in two months;
- smoking history of more than 10 pack years
You may not qualify if:
- diagnosed with unstable cardiovascular diseases, significant renal or hepatic dysfunction or mental incompetence;
- diagnosed with asthma, active pulmonary tuberculosis, diffuse panbronchiolitis, cystic fibrosis, clinically significant bronchiectasis, exacerbation of COPD or pneumonia in two months;
- prescribed immunosuppressive medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Related Publications (1)
Diao W, Labaki WW, Han MK, Yeomans L, Sun Y, Smiley Z, Kim JH, McHugh C, Xiang P, Shen N, Sun X, Guo C, Lu M, Standiford TJ, He B, Stringer KA. Disruption of histidine and energy homeostasis in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2019 Sep 3;14:2015-2025. doi: 10.2147/COPD.S210598. eCollection 2019.
PMID: 31564849DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chief in Department of Respiratory Medicine
Study Record Dates
First Submitted
October 10, 2017
First Posted
October 16, 2017
Study Start
December 10, 2015
Primary Completion
July 20, 2017
Study Completion
July 20, 2017
Last Updated
October 17, 2017
Record last verified: 2017-10