Relationship Between Metabolic Profile and Clinical Phenotype in Chronic Obstructive Pulmonary Disease

Overview

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.

Full Title of Study: “Compartmental Analysis of Metabolite Profiles Associated With Disease Phenotype in Smokers With and Without Chronic Obstructive Pulmonary Disease”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 20, 2017

Detailed Description

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.

The investigators hypothesize that: 1) smokers with COPD will have a metabolomics signature that is distinct from healthy non-COPD smokers; 2) this signature will be associated with clinically relevant manifestations of disease (e.g., GOLD classification, PFT).

The availability of biosamples from a well-characterized population of smokers with and without COPD, combined with our established in-house metabolomics expertise, will robustly allow to test these novel hypotheses. 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. Moreover, this strategy may identify previously unrecognized metabolic pathways that are dysregulated in COPD. Collectively, these data will be used to direct a prospective clinical study to determine the association between metabolomics signatures and clinical outcomes.

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Metabolites that can predict the progress of lung function
    • Time Frame: 3 months
    • The study is aimed to investigate the relationship between the metabolites and the progress of lung function in COPD

Secondary Measures

  • Metabolites that can predict the severity of emphysema
    • Time Frame: 3 months
    • The association between metabolites and emphysema is also investigated
  • Metabolites that are associated with inflammatory mediators
    • Time Frame: 3 months
    • The association between metabolites and inflammatory mediators is also investigated

Participating in This Clinical Trial

IInclusion Criteria:

1. males aged 40-80;

2. diagnosed with COPD according to the GOLD guidelines;

3. clinically stable patients without medication changes or exacerbation in two months;

4. smoking history of more than 10 pack years

Exclusion Criteria

1. diagnosed with unstable cardiovascular diseases, significant renal or hepatic dysfunction or mental incompetence;

2. diagnosed with asthma, active pulmonary tuberculosis, diffuse panbronchiolitis, cystic fibrosis, clinically significant bronchiectasis, exacerbation of COPD or pneumonia in two months;

3. prescribed immunosuppressive medications.

Gender Eligibility: Male

Minimum Age: 40 Years

Maximum Age: 80 Years

Investigator Details

  • Lead Sponsor
    • Peking University Third Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bei He, Professor and Chief in Department of Respiratory Medicine – Peking University Third Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.