Smoking Cessation Clinical Trial
Official title:
Adverse Airway Effects of Inhaled Nicotine From Tobacco and E-Cigarettes
The purpose of the study conducted at VA Medical Center in Miami is to determine if smoking
electronic cigarettes (known as e-cigarettes) that contain nicotine have less negative
effects than regular cigarettes on the person's respiratory health. We will assess this by
measuring pulmonary function tests, several body molecules and functionality of the airway
cells. We will also evaluate how smokers can maintain exclusive electronic cigarettes use.
In this study, some people will continue to smoke regular tobacco cigarettes while others
will switch to a nicotine-containing electronic cigarette.
The study will evaluate the airway epithelial effects of EC (electronic cigarettes) vapor
containing nicotine when used as a tobacco replacement tool. By using active cigarette
smokers as a comparator group, the study will increase our knowledge of whether the use of
ECs is more or less harmful than continuation of tobacco smoking. This study will examine the
in vivo effects of EC vapors in nasal ion transport and TGF-β levels as well as in serum
inflammatory biomarkers.
As the primary endpoint, nasal ion transport will be assessed by nasal potential difference
(NPD), which measures the voltage potential resulting from epithelial ion fluxes at the
mucosal surface in vivo. Ion transport across nasal epithelia is representative for findings
in distal airways. Since NPD directly measures the changes in ion transport expected to
influence mucociliary clearance (MCC) and therefore overall outcome and since changes of NPD
measurements are indirectly linked to lung function changes and MCC in trials with cystic
fibrosis patients, we believe that NPD lends itself as a reasonable surrogate for MCC for
this clinical trial.
As secondary endpoints, we will also measure TGF-ß levels in nasal secretions and expression
in nasal cells to correlate these with the level of CFTR and CaCC-mediated Cl- conductance
(CFTR is known to show decreased function with elevated TGF-β). In addition plasma samples
will be collected to study systemic markers of inflammation as well as toxic substances that
may result from vaping and smoking.
The design is a smoking replacement trial, in which we will compare changes in upper airway
ion transport and inflammation in smokers who switch to EC vaping versus subjects that
continue to smoke tobacco cigarettes. In addition, we will use the trial design to evaluate
the feasibility of using the EC as a means to quit tobacco use.
The study will last up to16 weeks with weekly visits. Subjects must replace completely
cigarettes with EC within the first 4 visits (week 4) and maintain exclusive use for the
following 12 visits. Adherence is asses with exhaled carbon monoxide and/or carboxyhemoglobin
when needed. The study involves scheduled blood draws for research samples.
There will be total of 16 visits to the study clinic. Besides blood draws and NPD, the study
will include questionnaires, lung function testing and adverse event recording.
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