Lung Microbiome and Inflammation in Early COPD
Part of paid clinical trials in New York, New York.
- Sponsor
- NYU Langone Health
- Study ID
- NCT02777879
- Status
- Recruiting
Conditions
- Chronic Obstuctive Pulmonary Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Bronchoscopy — PROCEDUREFlexible 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.
Study Details
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.
Key Dates
- Start date
- May 31, 2014
- Status verified
- Jan 2026
- Primary completion
- Aug 31, 2030
- Completion
- Aug 31, 2030
Study Design
- Enrollment
- 230 participants (estimated)
Arms
- Arm: Chronic Obstructive Pulmonary Disease (COPD)Case of early COPD (GOLD 1-2, FEV1/FVC\<70 and FEV1\>50%)
- Arm: ControlNo obstruction (FEV1/FVC\<70). Controls will be recruited after each case and will be matched by: age (±5 year), 2) gender, 3) smoking (±5 pack-year) and 4) BMI (±5).
Primary Outcome Measure
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 ]
Central Contacts
- Rosemary Schluger
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | Kathryn Norris Adrienne Scott Doreen J Addrizzo-Harris, MD (SUB_INVESTIGATOR) Rany Condos, MD (SUB_INVESTIGATOR) Stephanie Lau, MD (SUB_INVESTIGATOR) Ashwin Basavaraj, MD (SUB_INVESTIGATOR) Michael D Weiden, MD (SUB_INVESTIGATOR) Yonghua Li, MD (SUB_INVESTIGATOR) |