COPD Metabolome, Smoking Oxidants and Aberrant Ciliated Cell Function

NCT01974154 | Terminated

• 2 other identifiers: 1305013966RFA-HL-12-009
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

Cigarette smoking is the major cause of chronic obstructive pulmonary disease (COPD), the 4th cause of mortality in the US. Central to COPD pathogenesis is "ciliopathy", dysfunction of the airway ciliated cells that mediate transport of mucus to remove inhaled pathogens. The focus of this study is to carry out metabolic profiling of banked biologic samples and assess the hypothesis that COPD is associated with a unique metabolome in serum and lung epithelial lining fluid, and that subsets of the COPD metabolome are linked to the ciliopathy of COPD.

Conditions

COPD; Smoking

Keywords

COPD; Smoking; Non-smoker

Outcome Measures

Primary Outcomes (1)

• Gene expression changes in airway epithelium

  We will perform metabolic profiling of biologic samples to assess the hypothesis that smoking-induced COPD is associated with a unique metabolome in serum and lung ELF, and that subsets of the COPD metabolome are linked to the ciliopathy of COPD.

  One year

Study Arms (2)

Cohort I

A. Healthy nonsmokers B. Healthy smokers C. Healthy smokers/quit smoking D. COPD smokers E. COPD smokers/ quit smoking

Other: Cohort I

Cohort II

A. Smokers with normal spirometry and normal DLCO B. Smokers, normal spirometry, low DLCO

Other: Cohort II

Interventions

Cohort I OTHER

We will evaluate serum and lung ELF obtained by bronchoalveolar lavage, under previous protocols, from 159 individuals at baseline and at 0, 3, 6 and 12 months.

Cohort I

Cohort II OTHER

Quantify the cilia length on prepared slides from 67 cohort II samples of airway epithelium from biological samples were already obtained from subjects who were consented to participate in prior WCMC IRB approved protocols.

Cohort II

Eligibility Criteria

• Age: 18 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:

• All study subjects should be able to provide informed consent Males or females ages 18 years and older Must provide HIV informed consent Lung disease proven by at least one of the following: symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and/or (6) diseases of organs with known association with lung disease

You may not qualify if:

• Individuals not deemed in good overall health by the investigator will not be accepted into the study.
• Habitual use of drugs and/or alcohol within the past six months (Acceptable: Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria).
• Individuals with history of chronic lung disease, including asthma or with recurrent or recent (within three months) acute pulmonary disease will not be accepted into the study.
• Individuals with allergies to atropine or any local anesthetic will not be accepted into the study.
• Individuals with allergies to pilocarpine, isoproterenol, terbutaline, atropine or aminophylline will not be accepted into the study.
• Females who are pregnant or nursing will not be accepted into the study Any history of allergies to xylocaine, lidocaine, versed, valium, atropine, pilocarpine, isoproterenol, terbutaline, aminophylline, or any local anesthetic will not be included in the study Patient refuses consent

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College - Department of Genetic Medicine

New York, New York, 10021, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Lung epithelial lining fluid (ELF) obtained by bronchoalveolar lavage (BAL)

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking

Condition Hierarchy (Ancestors)

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

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: October 25, 2013
• First Posted: November 1, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

US (1)