NCT02777879 Lung Microbiome and Inflammation in Early COPD
| NCT ID | NCT02777879 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Chronic Obstuctive Pulmonary Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 230 participants |
| Start Date | 2014-05 |
| Primary Completion | 2030-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 230 participants in total. It began in 2014-05 with a primary completion date of 2030-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Rosemary Schluger
✉ Rosemary.Schluger@nyulangone.orgLeopoldo Segal, MD
PRINCIPAL INVESTIGATOR
New York University Medical School
Frequently Asked Questions
Who can join the NCT02777879 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Chronic Obstuctive Pulmonary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02777879 currently recruiting?
Yes, NCT02777879 is actively recruiting participants. Contact the research team at Rosemary.Schluger@nyulangone.org for enrollment information.
Where is the NCT02777879 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT02777879 clinical trial?
NCT02777879 is sponsored by NYU Langone Health. The principal investigator is Leopoldo Segal, MD at New York University Medical School. The trial plans to enroll 230 participants.