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 — PROCEDURE
    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.

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: Control
    No 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

Locations (1)

FacilityCityStateZIPSite coordinators
New York University School of MedicineNew YorkNew York10016
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)

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