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

Smoking Clinical Trial

Official title:

Evaluation of the Lungs of Normal Individuals With Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing and Bronchial Wall Biopsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224185
• Other study ID #: IRB0005004439
• Status: Completed
• Phase: N/A
• First received: September 20, 2005
• Last updated: April 29, 2016
• Start date: January 2004
• Est. completion date: September 2012

Study information

• Verified date: April 2016
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Other known NCT identifiers

• NCT00234325

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Diseases
• Smoking

Intervention

Procedure:
• Bronchopulmonary Lung Lavage
Lung Lavage is a Washing. Bronchoscopy consists of the passage via the mouth or nose of a flexible fiberoptic bronchoscopy into the airways. During the lavage (washing) procedure, sterile 0.9% saline (5 x 20 ml aliquots in 1 to 3 sites) is instilled into the lung and immediately suctioned back, washing off cells lining the airways. Once the fluid has been collected, the fluid is centrifuged and the cells are collected and counted.
• Bronchial Brushing
Bronchoscopy consists of the passage via the mouth or nose of a flexible fiberoptic bronchoscopy into the airways. During the brushing procedure, a small cytology brush is passed through the bronchoscope, and a small area of the airway wall is brushed gently (in up to 20 different sites in the large and small airways) to obtain epithelial cells lining the airway. Cells collected by airway brushing will be washed, counted, and evaluated for viability. They will also be studied for differential cell count by standard procedures. Collected airway cells will be used to carry out studies assess expression of various genes and to study viral gene transfer.
• Bronchial Wall Biopsy
This is a safe and widely used investigative method in pulmonary medicine. In this procedure, a small biopsy forceps is passed through the bronchoscope and, under direct vision, a small biopsy (in up to 5 sites) is obtained from the bronchial wall. A biopsy obtains tissue to a depth of 2-3 mm, and includes epithelial and subepithelial tissue.

Locations

Country	Name	City	State
United States	Department of Genetic Medicine, WMC of Cornell Univeristy	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	New York Presbyterian Hospital, Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate etiology of lung diseases	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.	9/31/2012	No
Secondary	Effect of smoking on the genes of airway epithelial cells	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.	9/31/2012	No