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

NCT02168673 | Completed

• 1 other identifier: 1102011549
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Smoking

Keywords

COPD; Cigarette Smoke; Smoker; Nonsmoker; ODF2; Cilia

Outcome Measures

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.

  One Year

Study Arms (2)

Group 1

Healthy non-smokers

Group 2

Healthy non-smokers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will involve healthy nonsmokers and healthy smokers.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine

New York, New York, 10021, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and cells obtained from the study may be kept for future genetic studies.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking; Cigarette Smoking

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Tobacco Smoking; Tobacco Use

Study Officials

• Ronald G Crystal, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 20, 2014
• Study Start: April 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 2, 2016

Record last verified: 2016-04

Locations

US (1)