Lung Microbiome and Inflammation in Early COPD
Recruiting · NCT02777879 · Observational (researchers observe without assigning treatment) · Lead sponsor: NYU Langone Health
View the official record on ClinicalTrials.gov →Interventions studied
Bronchoscopy
What this trial is about
This is a cross sectional case controlled study to assess lung microbiome and inflammation in smokers with and without Chronic Obstructive Pulmonary Disease (COPD). Investigators will look at active bacterial metabolic pathways in the lower airways using metagenomic and metabolomic approaches an assess relationships among microbiome, metagenome, metabolome and host immune responses in COPD and controls. Investigators believe COPD cases will have higher prevalence of pneumotype supraglottic predominant taxa (SPT) than matched controls.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Case definition: Smokers (\>20 pack-year) with airflow obstruction (FEV1/FVC\<70) and FEV1\>50% predicted (early COPD GOLD 1 or 2)
- Control definition: Smokers with normal spirometry will serve as controls.
Exclusion criteria
- FEV1 \< 50% NOT 70
- Significant cardiovascular disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.
- Diabetes mellitus
- Significant liver or renal disease
- Severe coagulopathy (INR \> 1.4, PTT \> 40 seconds and platelet count \< 150x103 cells).
- Pregnancy
- ETOH use of more than \>6 beers or \>4 mixed drinks daily
- Lack of capacity to provide informed consent.
- Antibiotic use within the prior 2months
Where it is running
1 location listed across 1 US state.
- New York University School of Medicine - New York, New York, United States