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

This study has been completed.
Sponsor:
Collaborators:
New York Presbyterian Hospital
Rockefeller University
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00224185
First received: September 20, 2005
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Smoking
Lung Diseases
Procedure: Bronchopulmonary Lung Lavage
Procedure: Bronchial Brushing
Procedure: Bronchial Wall Biopsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of the Lungs of Normal Individuals With Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing and Bronchial Wall Biopsy

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Evaluate etiology of lung diseases [ Time Frame: 9/31/2012 ] [ Designated as safety issue: No ]
    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:
  • Effect of smoking on the genes of airway epithelial cells [ Time Frame: 9/31/2012 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Specimens will be retained from both a blood draw and a bronchial wall biopsy which obtains tissue to a depth of 2-3 mm and includes epithelial and subepithelial tissue.


Enrollment: 196
Study Start Date: January 2004
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: Bronchoalveolar Lavage
    Procedure: 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.
    Other Name: Bronchial Washing
    Procedure: 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.
    Other Name: Lung Biopsy
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The source of potential subjects will be the population of 'normal', as defined by the eligibility criteria below, individuals in the New York metropolitan area and elsewhere. Up to one hundred volunteers will take part in the study each year. Accrual will be random with no bias as to gender or racial/ethnic group. All study individuals will be males or females that are 18 years or older and are able to provide informed consent. Advertisements will be posted at various educational institutions and hospitals and placed in newspapers in the New York metropolitan area. Paid volunteer referrals will also be used for patient recruitment.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224185

Locations
United States, New York
Department of Genetic Medicine, WMC of Cornell Univeristy
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
New York Presbyterian Hospital
Rockefeller University
Investigators
Principal Investigator: Ronald G Crystal, MD Department of Genetic Medicine, Weill Cornell Medical College
  More Information

No publications provided by Weill Medical College of Cornell University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00224185     History of Changes
Obsolete Identifiers: NCT00234325
Other Study ID Numbers: IRB0005004439
Study First Received: September 20, 2005
Last Updated: December 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Healthy individuals
smokers
ex-smokers
non-smokers

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2014