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

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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

Tracking Information
First Submitted Date June 10, 2014
First Posted Date June 20, 2014
Last Update Posted Date May 2, 2016
Study Start Date April 2011
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 19, 2014)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02168673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Modulation of Genes Responsible for Cilia Length by Exposure to Cigarette Smoke
Official Title Modulation of Genes Responsible for Cilia Length by Exposure to Cigarette Smoke
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and cells obtained from the study may be kept for future genetic studies.
Sampling Method Probability Sample
Study Population The study will involve healthy nonsmokers and healthy smokers.
Condition
  • COPD
  • Smoking
Intervention Not Provided
Study Groups/Cohorts
  • Group 1
    Healthy non-smokers
  • Group 2
    Healthy non-smokers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 20, 2015)
1
Original Estimated Enrollment
 (submitted: June 19, 2014)
20
Actual Study Completion Date April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02168673
Other Study ID Numbers 1102011549
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Weill Medical College of Cornell University
Study Sponsor Weill Medical College of Cornell University
Collaborators Not Provided
Investigators
Principal Investigator: Ronald G Crystal, MD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date April 2016