Evaluation of Lungs of Normal Individuals by Lung Lavage, Brushing and Bronchial Wall Biopsy

Completed

• Conditions: Smoking; Lung Diseases

• Registration Number: NCT00224185
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

The purpose of this study is to obtain biologic materials from the blood and lungs of normal individuals to establish a set of normal range for various parameters. These will provide important information when applied to individuals with various pulmonary diseases, and will help in understanding of the etiology and pathogenesis of various lung diseases.

Detailed Description

Study procedures will be performed at the Weill Cornell Medical College-New York Presbyterian Hospital and/or Weill Greenburg York Avenue Building. Study procedures done elsewhere that are within the protocol timeframe will be accepted if seen fit by the investigators so that they are not repeated unnecessarily. Study individuals who undergo bronchoscopy with intravenous administration of sedatives and analgesia may be required to stay overnight. Bronchoscopy is normally an ambulatory procedure. The subject is observed after the bronchoscopy, including vital signs and level of consciousness, until they are back to baseline. An overnight stay would only be required if the individual was not, in the judgment of the attending physician, safe to be discharged as is standard practice. Follow up of all participants are carried out by telephone within 1 wk following the procedure.

Rockefeller University has been added as a second site.

Individuals undergoing bronchoscopy without intravenous administration of sedatives and analgesia are not required to stay overnight due to the lack of administration of CNS-altering drugs and the limited sampling involved (tracheal brushes only).

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-29
• Last Update Posted: 2016-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• All study subjects should be able to provide informed consent
• Males or females ages 18 years and older.
• Must provide HIV informed consent.
• Non-smokers, ex-smokers and smokers.

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Exclusion Criteria

• Individuals not deemed in good overall health by the investigator will not be accepted into the study.
• Drug and/or alcohol abuse within the past six months.
• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate etiology of lung diseases	9/31/2012	We hope to learn more about the specific causes of lung disease, how lung disease manifests and progresses, and how lung disease can be treated.

Secondary Outcome Measures

Name	Time	Method
Effect of smoking on the genes of airway epithelial cells	9/31/2012	We hope to learn how smoking affects the genetic composition of the cells that line the airways (windpipes) of the lungs, and whether there are differences in the genetic composition of the cells that line the windpipe in normal individuals who smoke.

Trial Locations

Locations (1)

Department of Genetic Medicine, WMC of Cornell Univeristy; 🇺🇸 New York, New York, United States