Clinical trial NCT00224185: Evaluation of Lungs of Normal Individuals by Lung Lavage, Brushing and Bronchial Wall Biopsy
Official title: Evaluation of the Lungs of Normal Individuals With Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing and Bronchial Wall Biopsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Lung Diseases
Keywords: Healthy individuals
smokers
ex-smokers
non-smokers
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: New York Presbyterian Hospital
name: Rockefeller University
First posted: 2005-09-22
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

Eligibility 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

Primary outcomes:
measure: Evaluate etiology of lung diseases
timeFrame: 9/31/2012
Secondary outcomes:
measure: Effect of smoking on the genes of airway epithelial cells
timeFrame: 9/31/2012
Other outcomes:
Locations:
city: New York
country: United States
facility: Department of Genetic Medicine, WMC of Cornell Univeristy
state: New York
Study officials:
affiliation: Department of Genetic Medicine, Weill Cornell Medical College
name: Ronald G Crystal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang G, Wang R, Ferris B, Salit J, Strulovici-Barel Y, Hackett NR, Crystal RG. Smoking-mediated up-regulation of GAD67 expression in the human airway epithelium. Respir Res. 2010 Oct 29;11(1):150. doi: 10.1186/1465-9921-11-150.
citation: Carolan BJ, Harvey BG, Hackett NR, O'Connor TP, Cassano PA, Crystal RG. Disparate oxidant gene expression of airway epithelium compared to alveolar macrophages in smokers. Respir Res. 2009 Nov 17;10(1):111. doi: 10.1186/1465-9921-10-111.