NCT03310177

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

1.6 years

First QC Date

October 10, 2017

Last Update Submit

October 15, 2017

Conditions

Keywords

Chronic Obstructive Pulmonary DiseaseMetabolomics

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

Age40 Years - 80 Years
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

Locations