Lung Microbiome and Inflammation in Early COPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bronchoscopy.
- Who it may be relevant to
- Registry conditions: Chronic Obstuctive Pulmonary Disease. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Lung Microbiome and Inflammation in Early Chronic Obstructive Pulmonary Disease (COPD)
Overview
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.
Interventions
- Procedure Bronchoscopy
Flexible bronchoscopy with bronchoalveolar lavage (BAL) and bronchial brushings will be done in a standardized manner. The bronchoscope tip is sequentially wedged in sub-segments where BAL will be performed on a total of two segments of the lung (120 ml in each segment for a total of 360 ml). Two brushes will be done under direct visualization in both segments. Selection of segments to sample will be based on where abnormalities are in imaging.
Primary outcome measures
- Site specific microbiome (supraglotic area) constituents using background subtraction and source tracking approaches via a multivariable conditional logistic regression model. following broncho-alveolar lavage, BAL [Time frame: 4 Hours]
Secondary outcome measures (1)
- Bacterial metabolic pathways in the lower airways using metagenomic and metabolomic approaches [Time frame: 4 Hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- New York University School of Medicine — New York
Identifiers
NCT: NCT02777879 · 14-01546