Adverse Airway Effects From Tobacco and E-Cigarettes

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.

Study Overview

• Status: Unknown
• Conditions: Smoking Cessation; Airway Morbidity; Smoking, Tobacco; Smoking, Cigarette; Nicotine Adverse Reaction
• Intervention / Treatment: Device: Electronic cigarette use; Other: Control regular cigarette smokers

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33125
      • Recruiting
      • Miami VA Healthcare System
      • Contact: Michael Campos, MD; Email: MCampos1@med.miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects that actively smoke and have a history of at least 5 pack-years

Exclusion Criteria:

• HIV,marijuana use, asthma and other concomitant inflammatory pulmonary disorders, subjects with known pulmonary diseases including malignancies, subjects with prior thoracic surgery and subjects that used oral corticosteroids or antibiotics within the prior 3 months, subjects with allergies to study medications and subjects incapable of providing informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Electronic cigarette use; Subjects who try to switch to electronic cigarettes (EC) and subjects who successfully switch to EC.	Device: Electronic cigarette use; Replacement of tobacco smoking with electronic cigarette vaping
OTHER: Control regular cigarette smokers; Habitual smokers without EC use	Device: Electronic cigarette use; Replacement of tobacco smoking with electronic cigarette vaping; Other: Control regular cigarette smokers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in nasal potential difference (NPD)	nasal potential difference (NPD) before and after replacing tobacco cigarettes with electronic cigarettes	11 weeks of transitioning

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Inflammatory markers smoking to electronic cigarettes	TGF-ß levels in nasal secretions before and after replacing tobacco cigarettes with electronic cigarettes	11 weeks of transitioning

Collaborators and Investigators

• Sponsor: Miami VA Healthcare System
• Investigators: Principal Investigator: Michael Campos, Miami VA Healthcare System

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 28, 2016
• Primary Completion (ANTICIPATED): March 28, 2021
• Study Completion (ANTICIPATED): March 28, 2021

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: August 11, 2017
• First Posted (ACTUAL): August 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2017
• Last Update Submitted That Met QC Criteria: August 11, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 1251.09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes