Integrative-omics of the Disordered COPD Small Airway Epithelium

NCT02183818 | Completed

• 2 other identifiers: 1301013416R01HL118541
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

We aim to use an integrated network systems approach to analyze certain existing small airway epithelium (SAE) omic data sets at the genetic, epigenetic (methylation), gene expression, microRNA and metabolomic levels, to develop an initial model of network connectivities and key network pressure points relevant to SAE biology in health and disease.

Conditions

Smoking; COPD

Keywords

Smoking; COPD; Non-Smokers; Smokers

Outcome Measures

Primary Outcomes (1)

• Identification of network pressure points relevant to SAE biology confirmed by analyze of SAE data sets.

  Using an integrated network systems approach to analyze our extensive existing SAE omic data sets at the genetic, epigenetic (methylation), gene expression, microRNA and metabolomics levels, to develop an initial model of network connectivities and key network pressure points relevant to SAE biology in health and disease.

  One Year

Study Arms (2)

Healthy nonsmokers

Physical assessment, EKG, blood and urine draw, chest x-ray, pulmonary function test (PFT), and bronchoscopy

Smokers with COPD

Physical assessment, EKG, blood and urine draw, chest x-ray, pulmonary function test (PFT), and bronchoscopy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

New York Metropolitan Area residents

You may qualify if:

• Self-reported never-smokers, with current smoking status validated by the absence of nicotine metabolites in urine (nicotine less than 2 ng/ml and cotinine less than 5 ng/ml)
• Negative HIV serology
• Smokers with COPD (n=50)
• Self-reported current daily smokers with greater than or equal to 10 pack-yr, validated by any of the following: urine nicotine greater than 30 ng/ml or urine cotinine greater than 50 ng/ml
• Meeting GOLD stages I-III criteria for chronic obstructive lung disease (COPD) based on postbronchodilator spirometry
• Taking any or no pulmonary-related medication, including beta-agonists, anticholinergics, or inhaled corticosteroids
• Negative HIV serology
• Healthy nonsmokers (n=50)

You may not qualify if:

• Evidence of malignancy within the past 5 years
• Smokers with COPD (n=50)
• Individuals in whom participation in the study would compromise the normal care and expected progression of their disease
• Evidence of malignancy within the past 5 years

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Boehringer Ingelheim: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Smoking; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Behavior; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ronald G Crystal, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: July 8, 2014
• Study Start: April 6, 2015
• Primary Completion: November 17, 2016
• Study Completion: October 15, 2020
• Last Updated: May 28, 2021

Record last verified: 2021-05

Locations

US (1)