In-vivo Effects of E-cigarette Aerosol on Innate Lung Host Defense

Stopped early · Not applicable · Has a placebo group

Conditions studied: Smoking, Healthy

In brief

While e-cigs are commonly represented as safer alternatives to tobacco cigarettes, little is known regarding the health effects of their short- or long-term use. The responses and the e-cig components exerting these effects on the airways are largely unknown. This study will identify if specific e-cig flavors modify respiratory immune responses. This study will determine the effects of cinnamaldehyde (CA)-containing e-cigarettes on airway epithelial cell ciliary function (i.e., MCC) in humans. Additionally the study will determine the effects of CA-containing e-cigarettes on airway immune cells obtained through induced sputum (SI) after inhalation of CA-containing e-cig aerosols to determine CA-induced effects on a) immune cell function (e.g., phagocytosis, respiratory burst), b) immune cell surface phenotype, and c) mediator production in humans in vivo.

Key facts

Study ID

NCT03700892

Run by

University of North Carolina, Chapel Hill

People needed

19

Starts

2018-10-19

Expected to finish

2020-03-03

Last updated by the study team

2021-06-10

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• An equal number of participants who currently use a vaping device and those who do not use a vaping device
• Age 18-40
• Must have a Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV₁) of at least 80% of predicted. Participants who fall out of the normal range will be offered a copy of the test to share with their personal physician.

You may not qualify if…

• Any pre-existing lung disease (asthma, cystic fibrosis, etc.)
• Any significant chronic illness, such as, but not limited to, heart disease, uncontrolled hypertension, diabetes, auto-immune disease
• Any use of tobacco products (other than e-cig) in the past 3 months, or a greater than 10 pack year history of smoking cigarettes
• Pregnant or nursing women
• Participants with a history of radiation exposure in the past year which exceeds annual safe limits.

Where it is running

• UNC Center for Environmental Medicine, Asthma and Lung Biology — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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