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CompletedNCT02168673Updated May 2, 2016

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

An observational study in COPD and Smoking, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-02.

Sponsored by Weill Medical College of Cornell University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • COPD
  • Smoking

Keywords

  • COPD
  • Cigarette Smoke
  • Smoker
  • Nonsmoker
  • ODF2
  • Cilia
03

In context

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.

Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The study will involve healthy nonsmokers and healthy smokers.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1 participant (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Group 1

    Healthy non-smokers

  • Group 2

    Healthy non-smokers

06

What researchers measure

Primary outcomes

  1. Evidence that exposure to cigarette smoke will result in shorter cilia length in human airway epithelial

    Cilia length will be measured using three preparation techniques: air-dried cytospins, detached cilia on cytospins, and mounted hydrated aliquots of cells.

    Time frame: One Year

07

Study locations

1 site
  • Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine
    New York, New York 10021, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02168673
Lead sponsor
Weill Medical College of Cornell University
Responsible party
Sponsor
First posted
Jun 20, 2014
Start date
Apr 2011
Primary completion
Apr 2015
Completion
Apr 2015
Last update
May 2, 2016

Study contacts

Ronald G Crystal, MD
principal investigator · Weill Medical College of Cornell University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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