Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Modulation of Genes Responsible for Cilia Length by Exposure to Cigarette Smoke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02168673
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
Cigarette smoking is the major risk factor for developing chronic obstructive pulmonary disease (COPD). Patients with COPD have difficulty clearing mucus and debris from their airways. Even smokers who have not developed COPD may have difficulty clearing the airways. This is partly because smoking impairs the function of cilia, tiny hairs lining the airways that sweep out mucus to keep the airways clean. The investigators have found that smoking reduces the length of cilia, which may contribute to the worsened cilia function in smoking and COPD. This is true even in smokers who show no signs of lung disease. The investigators believe that smoking affects levels of genes in lung cells, resulting in shorter cilia.

Condition or disease
COPD Smoking

Detailed Description:
In this study, we will use bronchoscopy (inserting a scope into the lungs) to obtain lung cells by brushing cells from the airways and we will study genes that may be related to cilia length. Our goals are (1) to prove that exposure to cigarette smoke results in shorter cilia, (2) to learn which specific genes control cilia length, and (3) to learn how smoking affects the gene ODF2 and what effect this has on cilia. Understanding how smoking affects cilia may help us identify new ways to treat patients with COPD.

Layout table for study information
Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Modulation of Genes Responsible for Cilia Length by Exposure to Cigarette Smoke
Study Start Date : April 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Group 1
Healthy non-smokers
Group 2
Healthy non-smokers



Primary Outcome Measures :
  1. Evidence that exposure to cigarette smoke will result in shorter cilia length in human airway epithelial [ Time Frame: One Year ]
    Cilia length will be measured using three preparation techniques: air-dried cytospins, detached cilia on cytospins, and mounted hydrated aliquots of cells.


Biospecimen Retention:   Samples With DNA
Blood and cells obtained from the study may be kept for future genetic studies.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study will involve healthy nonsmokers and healthy smokers.
Criteria

Inclusion Criteria:

  • Must be capable of providing informed consent
  • Males and females, age 18 or older
  • Nonsmoking, validated by venous carboxyhemoglobin and urine nicotine and cotinine within range for nonsmoker without smoke exposure, matched with smoker group by age, sex, ethnic/racial group
  • Good overall health without history of chronic lung disease, including asthma, and without recurrent or recent (within 3 months) acute pulmonary disease
  • Normal physical examination
  • Normal routine laboratory evaluation, including general hematologic studies, general serologic/immunologic studies, general biochemical analyses, and urine analysis
  • Negative HIV, hepatitis B and C serology
  • Normal chest X-ray (PA and lateral)
  • Normal electrocardiogram
  • Females - not pregnant
  • No history of allergies to medications to be used in the bronchoscopy procedure
  • Not taking any medications relevant to lung disease or having an effect on the airway epithelium
  • Willingness to participate in the study

Exclusion Criteria:

  • Unable to meet the inclusion criteria
  • Pregnancy
  • Current active infection or acute illness of any kind
  • 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)
  • Evidence of malignancy within the past 5 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168673


Locations
Layout table for location information
United States, New York
Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Layout table for investigator information
Principal Investigator: Ronald G Crystal, MD Weill Medical College of Cornell University

Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02168673     History of Changes
Other Study ID Numbers: 1102011549
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Weill Medical College of Cornell University:
COPD
Cigarette Smoke
Smoker
Nonsmoker
ODF2
Cilia